Oncofocus

Oncofocus will tweet about matters related to Oncology. Views expressed are our own.

[Oncofocus @oncofocus]

Here is an explainer video on Novus AI, our AI-powered conference coverage platform that enables you to stay ahead of the game.

Novus AI allows you to -

- Observe real-time shifts in the competitive landscape
- Learn how newly released data is benchmarked against the approved regimens and data from the key clinical trials
- Access information on relevant sessions/posters with ease.

The integration of the AI engine with our in-house knowledge base enables easy retrieval of accurate and verified information. On top of all these features, you can always reach out to our experts with a click to get details on any conference topic.

We will start a live demo of our Novus AI platform in the third week of April. Please fill out this form (https://t.co/JluCRLZftz) if you are looking to elevate your conference coverage experience.

You can always write to us at [email protected].

#oncofocus #novusai #oncology #conferenceintelligence #competitiveintelligence #competitivelandscape #ai #data #clinicaltrials #biopharma #intelligence #biotech #healthcare #pharmaceuticals #conference #aacr #asco #aacr23 #aacr2023 #asco2023 #asco23

[Julian Chavarriaga @chavarriagaj]

#EAU26 Dr. Fonteyne on MDT in oligometastatic prostate cancer: Evidence is growing, but context matters.

🔹 STOMP & ORIOLE: MDT → excellent local control, delays progression
🔹 RADIOSA: MDT + ADT > MDT alone for PFS
🔹 ARTO: MDT + SOC improved PFS and may signal OS benefit

Yet major gaps remain:
• Most data come from metachronous disease
• Evidence in de novo oligometastatic HSPC is limited
• Patient selection is key
@uroweb @UroToday

[Raffaele Colombo @raffcolo]

IBI363 (PD-1/IL-2α-bias), co-development, co-commercialize it in the U.S, commercialization rights outside Greater China and the U.S

IBI343 (CLDN18.2 ADC), rights outside China

IBI3001 (EGFR/B7H3 ADC), option for the rights outside China

https://t.co/ExGD26tKWB

[Zach Klaassen @zklaassen_md]

Drug Approvals in 🇺🇸 for Prostate Cancer (2010-2025)

Go ahead and bookmark this beauty from @PBarataMD

@urotoday #ESMO25

[Rohan Paul @rohanpaul_ai]

💊 Not a very good news for Medical LLMs.

A new Mass General Brigham study shows leading LLMs often try to please the user in medical chats, and to do that, can output wrong advice.

Paper shows that default models will confidently echo bad medical assumptions, and that a small behavior nudge plus a 300-example fine-tune can push rejection of harmful requests to 99% to 100% without hurting core knowledge.

They built 50 trick questions that treat a brand drug and its generic as different, then asked 5 models to answer.

GPT-4, GPT-4o, and GPT-4o-mini agreed with the wrong premise 100% of the time, Llama3-8B agreed 94%, and Llama3-70B rejected fewer than 50%.

This behavior is sycophancy, the model goes along with a bad assumption even when it knows the 2 names are the same drug.

Adding a refusal cue and asking the model to recall the brand to generic link first raised rejections to 94% for GPT-4 and GPT-4o, 92% for Llama3-70B, and 62% for GPT-4o-mini.

Small supervised fine-tuning on 300 examples then generalized the skill, giving GPT-4o-mini 100% and Llama3-8B 99% rejection on new cancer drug tests.

The models also explained their rejections correctly in 79% and 70% of those cases, and scores on 10 standard medical benchmarks stayed about the same.

The recipe is simple, allow refusal, cue factual recall before answering, and fine-tune on illogical request pairs so the model spots and blocks false premises.

This work isolates a real failure mode and shows a low-cost way to harden medical chat systems fast.

Health systems should adopt the rejection hint + factual recall + small fine-tune pattern and monitor for regressions as base models change.

---

nature. com/articles/s41746-025-02008-z

[Oncofocus @oncofocus]

#ESMO2025 Presidential Symposium - DESTINY-Breast11 - T-DXd is set to enter neoadjuvant setting for HER2+ eBC

[Raffaele Colombo @raffcolo]

#ESMO25 kicks off tomorrow! This year, more than 130 abstracts on ADCs were accepted for oral and poster presentations, clearly highlighting how mature this field has become.

Yet, only six new ADCs will present FIH data for the first time.

Here the list!

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryEvents

🎯 The US FDA granted accelerated approval to @Boehringer's zongertinib (kinase inhibitor) for previously treated, unresectable/metastatic non-sqNSCLC with HER2 TKD activating mutations. (Ref 1)
❓ What proportion of NSCLC patients have HER2 TKD activating mutations?

🎯 The US FDA granted accelerated approval to @JazzPharma's dordaviprone (DRD2 antagonist and ClpP agonist) for previously treated, H3 K27M-mutant, diffuse midline glioma. (Ref 2)
❓ What are the other key assets being developed for this indication?

#ClinicalEvents

🔬 The Phase 3 EPCORE FL-1 trial of @Genmab and @abbvie's subcutaneous epcoritamab (CD20 x CD3 BsAb) + rituximab + lenalidomide (R2) vs R2 alone met its dual primary endpoints of ORR and PFS in R/R follicular lymphoma. (Ref 3)
❓ How do the outcomes compare against the benchmarks in R/R FL?

🔬 China's NMPA and the US FDA have approved the initiation of @AkesoInc's global, randomized Phase 2 COMPASSION-36 registrational trial of cadonilimab (PD-1 x CTLA-4 BsAb) + lenvatinib (multi-TKI) vs lenvatinib alone for the Tx of advanced hepatocellular carcinoma previously treated with atezolizumab and bevacizumab. (Ref 4)
❓ What is the rationale behind the study?

🔬 @Immutep received positive and constructive feedback from the US FDA regarding future clinical development of eftilagimod alpha (soluble LAG-3 protein) as a first-line Tx of R/M SCCHN with PD-L1 CPS <1. (Ref 5)
❓ What are the next steps for development of the LAG-3 agent in this indication?

#SpecialDesignations

⭐ The US FDA granted the Fast Track designation to @proteinqure's PQ203 (SORT1 targeting peptide drug conjugate) for the Tx of triple negative breast cancer. (Ref 6)
❓ What are the key unmet needs for this indication?

⭐ The US FDA granted the Fast Track designation to Dizal Pharmaceutical’s birelentinib (LYN/BTK dual inhibitor) for the Tx of R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of Tx, including a BTK inhibitor and a BCL-2 inhibitor. (Ref 7)
❓ What were the outcomes that supported the designation?

#DealandCollaborations

🤝 @SERB_Pharma and Y-mAbs Therapeutics, Inc. have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead commercial oncology asset, naxitamab (anti-GD2). (Ref 8)
❓ Which other key developers have anti-GD2 assets in their pipeline?

To know answers to these questions and for additional insights, write to us at [email protected].

🌐References:

1) https://t.co/D9Ni8EUeZr
2) https://t.co/HNWlAcNqjw
3) https://t.co/j3QuaWyxcX
4) https://t.co/mgCG1ocNHj
5) https://t.co/CiTrMyrPHn
6) https://t.co/UXj6N6W6nw
7) https://t.co/xNAV4E4u8C
8) https://t.co/v3uQmiYJr0

#Modeyso #Glioma #Lymphoma #Leukemia #HCC #SCCHN #BreastCancer #NSCLC #Oncofocus #oncology

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryEvents

🎯 @abbvie submitted a sNDA to the US FDA for AbbVie and @Roche's venetoclax (BCL-2 inhibitor) + acalabrutinib (fixed-duration, all-oral combo) in previously untreated patients with chronic lymphocytic leukemia. (Ref 1)
❓ What are the combo’s pros and cons vs approved CLL therapies?

#ClinicalEvents

🔬 @EliLillyandCo's Phase 3 BRUIN CLL-314 trial of pirtobrutinib (non-covalent, reversible BTK inhibitor) vs ibrutinib (covalent BTK inhibitor) met its primary endpoint of non-inferiority in ORR for chronic lymphocytic leukemia or small lymphocytic lymphoma. (Ref 2)
❓ How are these results expected to impact the treatment paradigm?

#SpecialDesignations

⭐ The US FDA accepted and granted Priority Review to @AstraZeneca's sBLA for neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab + chemo, then durvalumab mono for resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. (Ref 3)
❓ What were the outcomes based on which the sBLA was accepted?

⭐ The US FDA granted the Fast Track designation to @MAIABiotech's ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of NSCLC. (Ref 4)
❓ What is the current development status of ateganosine?

⭐ The US FDA granted the Fast Track designation to @CalidiBio's CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. (Ref 5)
❓ Who are the key players developing oncolytic virus?

⭐ The US FDA granted the Orphan Drug designation to @sanofi's SAR446523 (anti-GPRC5D) for the treatment of relapsed or refractory multiple myeloma. (Ref 6)
❓ What are the key unmet needs for this indication?

#Setbacks

🛑 @ExelixisInc discontinued the Phase 2/3 STELLAR-305 trial of zanzalintinib (multi-targeted TKI of VEGFR, MET, and the TAM kinases) + pembro vs placebo + pembro as a first-line treatment for PD-L1 CPS ≥1, R/M SCCHN, based on emerging Ph2 data, competition in SCCHN, and assessment of other potentially larger commercial opportunities. (Ref 7)
❓ What was the rationale for the Ph2/3 STELLAR-305 trial?

🛑 @GSK's Phase 3 COSTAR Lung trial of dostarlimab (anti-PD-1) + docetaxel ± cobolimab (anti-TIM-3) combinations did not meet the primary endpoint of improving OS vs docetaxel alone in advanced NSCLC that has progressed on prior PD-(L)1 therapy and chemo. (Ref 8)
❓ What are the other key Phase 3 trials ongoing in this indication?

To know answers to these questions and for additional insights, write to us at [email protected].

🌐 References:

1) https://t.co/AcdfyaEd02
2) https://t.co/7K1RzWQjqB
3) https://t.co/7WLM7yrPGV
4) https://t.co/j9YicrfRI0
5) https://t.co/34p5EYz6No
6) https://t.co/OqSAeqGSex
7) https://t.co/Gz69wze8D8
8) https://t.co/24yrCTqhZW

#Venclexta #CLL #Jaypirca #SLL #Sarcoma #Myeloma #LungCancer #Imfinzi #GastricCancer #NSCLC #SCCHN #Oncofocus #oncology

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryEvents

🎯 The EC approved @Bayer and Orion Pharma’s darolutamide (androgen receptor inhibitor) + androgen deprivation therapy for the Tx of metastatic hormone-sensitive prostate cancer. (Ref 1)
❓ How is this approval going to impact the Tx paradigm of mHSPC?

🎯 The EC approved @Roche's inavolisib (PIK3CA inhibitor) + palbociclib + fulvestrant for the Tx of PIK3CA-mutated, ER+ve, HER2-ve, LA/M breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine Tx. (Ref 2)
❓ What percentage of breast cancer patients have PIK3CA mutations?

#ClinicalEvents

🔬 In the Phase 3 FLAURA2 trial, @AstraZeneca's osimertinib (EGFR TKI) + chemotherapy demonstrated a statistically significant and clinically meaningful OS benefit vs osimertinib monotherapy as a first-line Tx of LA/M EGFRm NSCLC. (Ref 3)
❓ How is the OS data going to impact the competitive position of the regimen?

#SpecialDesignations

⭐ The US FDA granted the Breakthrough Therapy Designation to Revolution Medicines' elironrasib (RAS(ON) G12C inhibitor) for the Tx of KRAS G12C-mutated, LA/M NSCLC who have received prior chemotherapy and IO but have not been previously treated with a KRAS G12C inhibitor. (Ref 4)
❓ What are the key unmet needs for this indication?

⭐ The US FDA granted the Fast Track Designation to DualityBio's DB-1310 (HER3 ADC) for the Tx of advanced, unresectable or metastatic non-sqNSCLC with an EGFR exon 19 deletion or L858R mutation with disease progression on or after Tx with a 3rd gen. EGFR TKI and platinum-based chemotherapy. (Ref 5)
❓ What are the clinical outcomes that support the FTD?

⭐ The US FDA granted the Fast Track Designation to GenFleet Therapeutics and @VerastemOncolog's VS-7375 (KRAS G12D (ON/OFF) inhibitor) for the first-line Tx of KRAS G12D-mutated, LA/M adenocarcinoma of the pancreas, and for the Tx of KRAS G12D-mutated, LA/M PDAC who have received at least one prior line of standard systemic therapy. (Ref 6)
❓ Which other KRAS inhibitors are currently being developed for these indications?

#Setbacks

🛑 The US FDA issued a CRL regarding the BLA for @Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the Tx of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form. (Ref 7)
❓ How will the setback impact Replimune’s pipeline and launch plans?

To know answers to these questions and for additional insights, write to us at [email protected].

🌐 References:

1) https://t.co/phLuTZAN5G
2) https://t.co/AeluBWCSsB
3) https://t.co/Q3QugbAorR
4) https://t.co/DbzZE8jrl8
5) https://t.co/2Gk6Qfpg0I
6) https://t.co/GmQdOTdmxD
7) https://t.co/I9PEPbq0L2

#Nubeqa #ProstateCancer #Itovebi #BreastCancer #Tagrisso #LungCancer #NSCLC #PancreaticCancer #PDAC #ADC #Melanoma #CRL #Oncofocus

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #CHMPMeetingHighlights (Oncology specific)

Highlights from the CHMP July 2025 Meeting are out!

#NewMedicines

💊 @Servier's vorasidenib (Voranigo; IDH1/2 inhibitor) monotherapy for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy

#NewBiosimilars

💊 Henlius' denosumab (Bilprevda; anti-RANKL) for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity

#IndicationExpansions

💊 @BeOneMedicines’ tislelizumab (Tevimbra; anti PD-1) in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence

👉 Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at [email protected], and we will take it from there.

🌐 Reference: https://t.co/lfxvvaUIRB

#vorasidenib #Voranigo #astrocytoma #oligodendroglioma #denosumab #Bilprevda #giantcelltumour #Tislelizumab #Tevimbra #NSCLC #oncology #Oncofocus #CHMP @BeOneMedicines

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryUpdates

🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol modulator) to treat patients with platinum-resistant ovarian cancer. (Ref 1)
❓ What are the clinical outcomes that support the NDA submission?

#SpecialDesignations

⭐ The US FDA granted the Priority Review to Johnson & Johnson’s TAR-200 (intravesical gemcitabine releasing system) for the Tx of BCG unresponsive high-risk non-muscle invasive bladder cancer with CIS, with or without papillary tumors. (Ref 2)
❓ What are the other key assets being developed for BCG unresponsive HR-NMIBC?

⭐ The US FDA granted the Breakthrough Therapy Designation to @DaiichiSankyoUS and @AstraZeneca trastuzumab deruxtecan (HER2 ADC) + @Roche's pertuzumab (anti-HER2) for the first-line Tx of unresectable or metastatic HER2+ve breast cancer. (Ref 3)
❓ How does the clinical efficacy of the combo compare against the SOC options for HER2+ve BC?

⭐ The US FDA granted the Fast Track Designation to Zenith Epigenetics’ ZEN-3694 (BET inhibitor) + abemaciclib for the Tx of metastatic or unresectable NUT carcinoma in patients who have received at least one line of prior chemotherapy. (Ref 4)
❓ What are the key unmet needs for this indication?

#ClinicalUpdates

🔬 The first patient has been successfully enrolled in the registrational Phase 3 AK112-312/HARMONi-GI6 trial of @AkesoInc and @SMMT_TX's ivonescimab (PD-1 x VEGF BsAb) + FOLFOXIRI as a first-line Tx for advanced metastatic colorectal cancer. (Ref 5)
❓ What are the other ongoing Phase 3 trials of ivonescimab?

#DealandCollaborations

🤝 @IMabBiopharma entered into a definitive agreement to acquire 100% ownership of Bridge Health Biotech which will provide I-Mab with the rights to bispecific and multi-specific applications, based on the CLDN18.2 parental antibody used in givastomig (CLDN18.2 x 4-1BB BsAb). (Ref 6)
❓ Who are the key players developing bispecifics with CLDN18.2 as one of the targets?

To know answers to these questions and for additional insights, write to us at [email protected].

🌐 References:

1) https://t.co/wavLLT8Gfj
2) https://t.co/0qeRGPOXKc
3) https://t.co/6WiHktxyGl
4) https://t.co/sVI4jTEjlN
5) https://t.co/RkAbomoX9r
6) https://t.co/NDBqIzvbkA

#OvarianCancer #BladderCancer #NMIBC #CRC #ColorectalCancer #Enhertu #BreastCancer #ADC #BsAb #Oncology #Oncofocus

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryUpdates

🎯The EC approved @BeOneMedicines' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the first-line Tx of metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. (Ref 1)
❓What are the other key Asia-specific trials emerging in this indication?

🎯The UK’s MHRA granted marketing authorization to @ImmunityBio's nogapendekin alfa inbakicept-pmln (lymphocyte-stimulating agent) + BCG for the Tx of BCG-unresponsive NMIBC Carcinoma In Situ. (Ref 2)
❓What are the clinical outcomes that support this approval?

🎯The US FDA approved @SirtexMedical 's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC. (Ref 3)
❓How does this therapy compare against the existing SOC options?

#SpecialDesignations

⭐The US FDA granted the Breakthrough Device designation to ArteraAI's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer. (Ref 4)
❓Who are the other key players developing similar AI tools?

⭐The US FDA granted the Fast Track designation to Trethera Corporation's TRE-515 (dCK inhibitor) + radioligand therapy for the Tx of PSMA+ve metastatic CRPC. (Ref 5)
❓What are the key unmet needs for this indication?

⭐The US FDA granted the Orphan Drug designation to @arcusbio' quemliclustat (CD73 inhibitor) for the Tx of pancreatic cancer. (Ref 6)
❓Which are the key assets in the competitive landscape for pancreatic cancer?

#DealandCollaborations

🤝 Adagene announced a partnership with ConjugateBio to provide a proprietary antibody for use in partner companies’ bispecific ADC development programs. Under the terms of the agreement, Adagene will receive an undisclosed upfront payment, as well as milestone and royalty payments, and will provide an internally developed antibody for novel bispecific ADC development. (Ref 7)
❓Which other companies have promising bispecific ADCs?

🤝 @CARGOTx entered into a definitive merger agreement with Concentra Biosciences, whereby Concentra will acquire CARGO for $4.379 in cash per share of CARGO common stock, par value $0.001 per share, plus one non-transferable contingent value right. The merger transaction is expected to close in August 2025. (Ref 8)
❓Which are the key assets of interest from CARGO’s pipeline?

To know answers to these questions and for additional insights, write to us at [email protected]

🌐 References:

1) https://t.co/0vsOXvHekb
2) https://t.co/MVJZDapj0j
3) https://t.co/RgeM1i1hyR
4) https://t.co/FSjJKxfRZx
5) https://t.co/UusTYay6Oo
6) https://t.co/1VV4Fxc3Se
7) https://t.co/wjH21z8UiE
8) https://t.co/CcxP8fwwq1

#TEVIMBRA #NPC #NMIBC #BladderCancer #ANKTIVA #LiverCancer #HCC #ProstateCancer #PancreaticCancer #ADC #bispecific #Oncology

[Oncofocus @oncofocus]

@SMMT_TX has reportedly been in partnership discussions with @AstraZeneca and other major pharma companies for its sole asset, Ivonescimab (PD-1xVEGF BsAb) (Ref 1).

The potential deal, which could be valued at a staggering ~$15 billion (or higher?), would give a significant return on investment for Summit, which acquired the rights to ivonescimab from @AkesoInc in Dec 2022 in a transaction worth up to $5 billion, with a $500 million upfront payment (Ref 2).

If finalized, the partner would gain access to the promising BsAb that demonstrated superiority over Merck & Co/@MSDInvents's blockbuster drug Keytruda (pembrolizumab) in multiple pivotal trials conducted in China (Ref 3).

However, in the global HARMONi trial, though ivonescimab demonstrated a significant PFS benefit (a primary endpoint), it failed to achieve significant OS benefit (another primary endpoint) vs platinum-doublet chemo in EGFR+ve, LA/M non-squamous NSCLC (Ref 4).

Additionally, the US FDA feedback creates regulatory hurdle, as the agency specified that "a statistically significant OS benefit is necessary to support marketing authorization". Nevertheless, Summit intends to file the BLA and will consider the timing of the filing based on the discussions with the FDA (Ref 4).

Besides the HARMONi trial, ivonescimab is also being studied in two additional, Global Phase 3 trials in NSCLC (Ref 5).

Moreover, as a part of ivonescimab's broader development plan, Summit has also established clinical collaborations to evaluate ivonescimab with @pfizer's ADCs and @Rev_Medicine's RAS(ON) Inhibitors (Ref 6, 7).

Overall, the success of ivonescimab triggered a significant interest in the PD-(L)1/VEGF bispecific space, with major companies like @bmsnews, @MSDInvents, and @pfizer_news making substantial investments in similar BsAbs.

BMS entered $11 billion partnership with @BioNTech_Group for BNT327 (PD-L1xVEGF-A BsAb, originally developed by Biotheus, a China-based company acquired by BioNTech in 2024), MSD paid $588 million upfront ($2.7 billion in milestone payments) for LaNova Medicines' LM-299 (PD-1xVEGF BsAb), and Pfizer spent $1.25 billion upfront (~$4.8 billion in milestone payments) on 3SBio Inc.'s SSGJ-707 (PD-1xVEGF BsAb) (Ref 8, 9, 10, 11).

Some of the other major pharma players are also trying to catch up in the field through partnerships. It will be interesting to see whether AstraZeneca or another company ultimately partners with Summit for ivonescimab.

References:
1. https://t.co/kIIVVE38st
2. https://t.co/godWgmPala
3. https://t.co/RFzpLTkOAC
4. https://t.co/OPby4z7rbI
5. https://t.co/ycX8TTZ8xQ
6. https://t.co/4WThq870Oe
7. https://t.co/O4Z2Qs1Vze
8. https://t.co/XKfkAJSuIm
9. https://t.co/bajLCSlfpm
10. https://t.co/pvn5ZV9Ver
11. https://t.co/hhfjxnaVpB

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryUpdates

🎯 The US FDA granted accelerated approved for Dizal Pharmaceutical’s sunvozertinib (EGFR TKI) for the Tx of adult patients with LA/M NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemo. (Ref 1)
❓ How does sunvozertinib compare with Johnson & Johnson’s previously approved Rybrevant (amivantamab)?

🎯 The US FDA granted accelerated approval for @Regeneron’s linvoseltamab-gcpt (BCMA x CD3 BsAb) for patients with R/R multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody (Ref 2)
❓What are the pros and cons of linvoseltamab?

🎯 The EC granted conditional marketing authorization for @JazzPharma’s zanidatamab (dual HER2-targeted BsAb) mono for the Tx of adults with unresectable LA/M HER2+ve (IHC 3+) biliary tract cancer previously treated with at least one prior line of systemic therapy. (Ref 3)
❓ What percentage of biliary tract cancers are HER2+ve?

🎯 The China NMPA granted approval for @hutchmed's NDA for savolitinib (MET TKI) + osimertinib (EGFR TKI) for the Tx of LA/M, EGFR +ve NSCLC with MET amplification after disease progression on EGFR TKI. The approval also triggered a US$11 million milestone payment from @AstraZeneca, which markets both savolitinib and osimertinib in China. (Ref 4)
❓ How would this impact the current SoC for EGFR+ve NSCLC in China?

🎯 The UK's NICE terminated the appraisal of @bmsnews’ adagrasib (small molecule inhibitor of KRAS G12C mutant isoform) for previously treated KRAS G12C+ve advanced NSCLC. (Ref 5)
❓ What are the next options for BMS in the UK?

#ClinicalUpdates

🔬 @Amgen's Phase 3 FORTITUDE-101 trial of bemarituzumab (anti-FGFR2) + chemo met its primary endpoint of OS at a pre-specified interim analysis vs placebo + chemo as a first-line Tx of unresectable, LA/M gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 +ve. (Ref 6)
❓ What are the other key Phase 3 trials ongoing in this indication?

To know answers to these questions and for additional insights, write to us at [email protected].

🌐 References:

1) https://t.co/B8gRiLJMD9
2) https://t.co/gtmx44nWkU
3) https://t.co/kguPFpFp7E
4) https://t.co/G6KV0D94yy
5) https://t.co/bt34xEDqAf
6) https://t.co/LV2ePfZ9dB

#Krazati #Ziihera #BTC #ZEGFROVY #Lynozyfic #Myeloma #TAGRISSO #ORPATHYS #NSCLC #LungCancer #GC #Gastric #GEJC #Oncology #Oncofocus

[Oncofocus @oncofocus]

📢 @abbvie is set to acquire @Penn’s spinout, Capstan Therapeutics for up to $2.1 billion in cash, representing one of the major acquisitions in the CGT space in 2025.

⭐ The acquisition price represents a significant premium over Capstan's last valuation, however, with this deal AbbVie gains full access to Capstan's key programs and most importantly its proprietary in vivo cell engineering technology, which was developed by the world-renowned scientists.

⭐ Moreover, the Capstan’s technology was backed by the venture arms of Big Pharma, including Pfizer, Bayer, Eli Lilly, Bristol Myers Squibb and Novartis.

⭐ Recent high-profile transactions, including @AstraZeneca's acquisition of EsoBiotec, demonstrate the market's willingness to assign substantial valuations to promising in vivo platforms.

👉Click on this link to access slide deck with additional details - https://t.co/dxIWUWr90v

📧 For further details, please write to us at [email protected].

🌐 References:

1) https://t.co/Xas6znkmPC
2) https://t.co/cbyby8a5xZ
3) https://t.co/3Q9J5Kncl9

#Deals #Mergers #Acquisitions #CAR #CellTherapy #InVivo #Immunology #Oncology #Oncofocus

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryUpdates

🎯 @DaiichiSankyoUS and @AstraZeneca's Dato-DXd (Datroway; TROP2 ADC) has been granted an accelerated approval by the US FDA for the Tx of EGFR+ NSCLC patients previously treated with EGFR directed therapy and platinum-based chemotherapy. (Ref 1)
❓ Which other key regimens are expected to enter this setting in the near future?

#SpecialDesignations

⭐ enGene's detalimogene voraplasmid (non-viral gene therapy) was granted a Regenerative Medicine Advanced Therapy (RMAT) designation by the US FDA for the Tx of BCG unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. (Ref 2)
❓ What are the current Tx options and benchmarks in this setting?

⭐ The US FDA granted a Priority Review to @Syndax’s supplemental NDA of revumenib (Revuforj; selective menin inhibitor) for the Tx of relapsed or refractory AML with NPM1 mutation. The PDUFA date has been set for Oct 25, 2025. (Ref 3)
❓ What is the projected revenue increase for Revuforj following the anticipated label extension?

⭐ The US FDA granted a Breakthrough Therapy Designation to Revolution Medicines’ daraxonrasib (RAS(ON) multi-selective inhibitor) for the Tx of previously treated metastatic PDAC in patients with KRAS G12 mutations. (Ref 4)
❓ Which other assets targeting these patients received special designations? How do they compare?

⭐ QBiotics' tigilanol tiglate (intratumoural oncolytic agent) elicited an ORR of 80.0% in advanced and/or metastatic soft tissue sarcoma patients in stage 1 part (n=10) of the Phase 2a, QB46C-H07 trial. (Ref 5)
❓ What are the current benchmarks in this setting?

#ClinicalUpdates

🔬 The Ph3 STELLAR-303 trial of @ExelixisInc' zanzalintinib (thrid generation multi-target TKI) + Roche’s atezolizumab (Tecentriq; anti-PD-L1) demonstrated a statistically significant improvement in OS vs Bayer’s regorafenib (Stivarga; multi-kinase inhibitor) in previously treated non-MSI-H CRC patients, regardless of liver metastases. (Ref 6)
❓ Can the zanzalintinib + atezolizumab combo be the next SoC for these patients?

#Setbacks

🛑 @Philogen3 withdrew its EMA marketing authorisation application for Nidlegy (daromun; L19IL2 + L19TNF) as a neoadjuvant Tx for adults with locally advanced, fully resectable melanoma, due to unavailability of CMC and additional clinical data in the allowed time period. (Ref 7)
❓ What is the current SoC for the Tx of resectable Melanoma?

🌐 References:

1) https://t.co/RH31cZeOAK
2) https://t.co/aMdSWL4xE9
3) https://t.co/1DnusxdfiL
4) https://t.co/O1qwWYOln6
5) https://t.co/DGIi1lTmMy
6) https://t.co/NjWDQHMImF
7) https://t.co/xLquIwVwWT

#datopotamabderuxtecan #NSCLC #USFDA #genetherapy #SoftissueSarcoma #ColorectalCancer #TyrosineKinaseInhibitor #Melanoma #oncology #oncofocus

[Oncofocus @oncofocus]

#StayAheadWithOncofocus #KeyCellTherapyUpdates (Weekly)

#RegulatoryUpdates

🎯 @SentiBio received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1)
👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months)

🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1 CertainT-1/NCT06834282 trial for AML (Ref 2)
👉 Why it matters: CER-1236 is the first T cell therapeutic targeting TIM4L with built-in phagocytic activity, offering a precise way to treat AML while sparing healthy cells.

#ClinicalDataReadouts

🔬 @bmsnews presented first-time detailed results from the MZL cohort of the Ph2 TRANSCEND FL/NCT04245839 trial evaluating Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) in 3L+ setting. In 66 evaluable pts, ORR was 95.5% (CR: 62.1%) (Ref 3)
👉 Why it matters: This data could pave the way for extending Breyanzi’s label to a fifth B-cell malignancy

🔬 Lyell Immunopharma presented updated Ph1/2, NCT05826535 results evaluating LYL314 (anti-CD19/CD20 dual-targeting CAR-T) in 3L+ LBCL pts. In 25 evaluable pts, ORR was 88.0% (Ref 4)
👉 Why it matters: Recent CD19/CD20 dual CAR-T updates reveal a growing competitive space, with early data suggesting superior efficacy over currently approved therapies

🔬 At ICML’25, @GalapagosGlobal presented data from the Ph1/2 ATALANTA-1/NCT06561425 trial evaluating GLPG5101 (an autologous, freshly prepared anti-CD19 CAR-T) in 34 pts with R/R indolent NHL (FL, n=29; MZL, n=5) (Ref 5)
👉 Why it matters: Preliminary clinical data demonstrated the feasibility of Galapagos’ decentralized manufacturing platform. Long-term results are needed for further validation

🔬 First time results from the Ph1, NCT05838131 trial evaluating CARsgen Therapeutics’ CT071 (an autologous, anti-GPRC5D CAR-T) for high-risk newly diagnosed MM, showed 100% ORR in 10 pts (Ref 6)
👉 Why it matters: Early-line studies mark a new chapter for CAR-Ts in MM, building on later-line success

#Setback

🛑 @BioNTech_Group discontinued the development of BNT211 (an autologous, anti-CLDN6 CAR-T) for Testicular Cancer based on the Ph1/NCT04503278 readout (Ref 7)
👉 Why it matters: BioNTech is shifting away from cell therapies by dropping the Autolus AUTO1/22 co-development option & winding down the cell therapy manufacturing facility

To know answers to these questions and for additional insights, write to us at [email protected].

🌐 References:

1) https://t.co/7mMjcWERyV
2) https://t.co/Cf7uSooCUR
3) https://t.co/lp3Qyl0V9L
4) https://t.co/Bm2HLvfSPx
5) https://t.co/TQfbLEwWh3
6) https://t.co/A5ZcUyVTzP
7) https://t.co/RGY3fPaiQJ

#Senti202 #CT071 #CARNK #GLPG5101 #MZL #LYL314 #CART #LBCL #USFDA #CERT1236 #CERT #Breyanzi #Lymphoma #MM #autologous #Oncology #oncofocus

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #CHMPMeetingHighlights (Oncology specific)

Highlights from the CHMP June 2025 Meeting are out!

#NewMedicines

💊 Cordex Biologics' (an @Excellthera company) dorocubicel (Zemcelpro; UM171 Cell Therapy) has been recommended for a conditional marketing authorisation for the treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available.

#IndicationExpansions

💊 @ExelixisInc , Ipsen and @TakedaPharma's cabozantinib (Cabometyx; multiple tyrosine kinase inhibitor) is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

💊 @JNJInnovMed's daratumumab (Darzalex; anti-CD38) monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma.

💊 @JNJInnovMed and @abbvie's ibrutinib (Imbruvica; BTK inhibitor) in combination with @Roche 's rituximab (anti-CD20 mAb), cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).

💊 @Bayer and Orion Pharma darolutamide (Nubeqa; oral androgen receptor inhibitor) in combination with androgen deprivation therapy is indicated for the treatment of adult men with hormone-sensitive metastatic prostate cancer.

💊 @sanofi's isatuximab-irfc (Sarclisa; anti-CD38) in combination with bortezomib, lenalidomide, and dexamethasone is indicated for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

🌐 Reference: https://t.co/HNhBVIbpy0

#Zemcelpro #cabozantinib #Cabometyx #daratumumab #Darzalex #ibrutinib #Imbruvica #darolutamide #Nubeqa #isatuximabirfc #Sarclisa #multiplemyeloma #lymphoma #MCL #prostatecancer #oncology #Oncofocus #CHMP #EMA

[Oncofocus @oncofocus]

#StayAheadWithOncofocus - #KeyOncologyNews (selected)

#RegulatoryEvents

🎯 The US FDA approved the updated labelling of @pfizer talazoparib (PARP inhibitor) + enzalutamide (androgen receptor inhibitor) for mCRPC to include the final OS data for the combo’s existing indication for the Tx of HRR gene-mutated mCRPC, but did not expand the indication to include non-HRR gene mutated patients. (Ref 1)
❓ What were the key factors that influenced the FDA’s decision to not expand the indication?

🎯 The US FDA approved @Incyte tafasitamab (anti-CD19) + rituximab + lenalidomide for the Tx of adults with relapsed or refractory follicular lymphoma (Ref 2)
❓ How is the combination positioned against the current SOC?

#SpecialDesignations

⭐ The US FDA granted the Orphan Drug Designation to Medicovestor, Inc.’s ADoBind MC001 (Frα ADC) for the Tx of pancreatic cancer. (Ref 3)
❓ What are the other key ADCs in pancreatic cancer with an ODD?

⭐ The US FDA granted the Orphan Drug Designation to Circle Pharma, Inc.’s CID-078 (Cyclin A/B RxL inhibitor) for the Tx of SCLC. (Ref 4)
❓ What are the key unmet needs in the SCLC space?

#DealandCollaborations

🤝 @PierreFabre acquired the worldwide rights for PFL-721 (STX-721; EGFR/HER2 ex20 inhibitor) and PFL-241 (STX-241; EGFR inhibitor) from Antares Therapeutics, a spin-out of Scorpion Therapeutics. Both assets are currently being evaluated as a Tx for NSCLC. (Ref 5)
❓ How are these assets positioned in the NSCLC pipeline landscape?

🤝 Crescent Biopharma completed its merger with GlycoMimetics, with the combined company operating under the name Crescent Biopharma, Inc. The company’s pipeline includes bispecific antibodies such as the CR-001, a tetravalent PD-1 x VEGF BsAb, and CR-002 and CR-003, which are novel ADCs. (Ref 6)
❓ How is this merger going to impact the BsAb and ADC space?

🤝 NextCure, Inc. entered a strategic partnership with Simcere Zaiming for the development of SIM0505 (CDH6 ADC) in solid cancers. As a part of the agreement, NextCure gained global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights. (Ref 7)
❓ What is the development status of SIM0505 in solid tumor indications?

#Setbacks

🛑 @abbvie's Phase 3 VERONA trial of venetoclax (BCL-2 inhibitor) + azacitidine did not meet the primary endpoint of OS (HR 0.908; p=0.3772) vs azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). (Ref 8)
❓ How is this failure going to impact AbbVie’s MDS program?

To know answers to these questions and for additional insights, write to us at [email protected].

🌐 References:

1) https://t.co/wOEHvSrQVb
2) https://t.co/m8zp85n74I
3) https://t.co/Djoj7PJ4zW
4) https://t.co/rUbOGKHY74
5) https://t.co/4ckb4KA9Pg
6) https://t.co/0IjPMKOq34
7) https://t.co/UAigHgzQht
8) https://t.co/DtgIOlkpSU

#mCRPC #ADC #BsAb #PancreaticCancer #MDS #SCLC #NSCLC #LungCancer #ODD #Oncology #Oncofocus