We now have release of SUCCESSOR-2 data!
Mezi + weekly Kd vs twice weekly Kd
- 85% anti cd38 refractory
- mPFS 18 vs 8 months (control arm did the same as MajesTEC-9)
My take: 18 months is nothing to scoff at, and compares favorably with KPd data. It still leaves something to be desired compared to other options in the same lines BUT one more time for those in the rafters - we can stop using Kd and VPd as comparator arms now?
🔴Online now: Inter-rater reliability of CTCAE assessments with or without EORTC PRO data in a mixed cancer population: a multinational, open-label, RCT from @EORTC_QLG
https://t.co/YQhwVkABnK
AND
✏️Linked Comment by @EthanBasch1, @BiostatGirl
https://t.co/YQhwVkABnK
#Myeloma Paper of the Day: IMWG immunotherapy committee makes recommendations on sequencing immunotherapy for treatment of myeloma, including to avoid high-dose alkylators & bendamustine, give bridging if high disease burden, and CAR T before TCE: https://t.co/vzxYgPaIk8. #mmsm
While a noble sentiment, Dara-KRD is neither FDA approved nor listed by NCCN as a category 1 (or even a preferred) regimen (due to a lack of Phase III data). The counterargument then is that you raise false expectations & put the patient at risk of financial toxicity.
#Myeloma Paper of the Day: Systematic review & meta-analysis of outcomes of hematopoietic stem cell transplant in primary plasma cell leukemia finds pooled 3 years OS, PFS/EFS & relapse rate (RR) in auto-HCT were 51%, 36 %, and 68%, respectively: https://t.co/EwohVvUopE. #mmsm
2024 FDA Novel Drug Approvals (with segmentation by manufacturer, indication and supporting clinical trials)
The agency has approved 55 novel drugs so far, with 47 via CDER and 8 via CBER
Other takeaways:
• This is 22% behind 2023 which saw 71 approvals (16 CBER, 55 CDER) - it's worth noting that the 2023 CDER approval count was the 2nd highest total in 30 years (the peak was 59 in 2018)
• The 47 CDER approvals in 2024 would be in-line with the 10-year historical annual average of 46
• The CDER 10-year rolling average of 46 approvals is the highest it has been in over 20 years and a significant leap from 2010, when it bottomed out at 25
• 2024 saw one of the highest counts of accelerated approvals, although most had active Phase 3 studies at the time of approval, reflecting a reform to the multi-year delays we had seen in previous years
• We saw a few FDA approvals for assets coming out of China, which is a metric worth monitoring as many companies and investors evaluate their BD strategy in the region
• This excludes diagnostics, drugs approved via the 505(b)(2) pathway and source plasma
Compiled using @sleuthinsights - comment below if you'd like a PDF and we'll get it over to you!
So that is how smart trial design help you to get impressive PFS results .
You select pts with good biology at the end of induction chemo and then give them additional treatment that control arm good biology pts dont get and show that PFS becomes better .
Excellent discussion by Dr Sara Hurvitz 👏.
1- I hope this shows OS if when this data becomes mature .
I don't think it will show OS if control arm gets cdk inhibitors on progression in sufficient number
2- question for clinical practice is if additional cdk inhibitor is better then why not add abemaciclib or ribociclib ( they are supposed to be better than palbociclib- or we are back to agreeing that all cdk inhibitors are same ? )
3 - what happens when control arm of this trial is no more SOC and tdx1 becomes SOC post destiny 09 results .
@ErikaHamilton9@hoperugo@stolaney1@drsarahsam@DrHBurstein@brunolarvol@OncoAlert
Post #ASH24. Active myeloma drugs in one table with mechanism of action.
Revised slide. Bookmark!
Black font — Approved drugs
Blue font — Investigational
#ASH24VR
Current development of chimeric antigen receptor T‐cell therapy for diffuse large B‐cell lymphoma and high‐grade B‐cell lymphoma - Yamauchi - European Journal of Haematology - Wiley Online Library https://t.co/tk2WhCU0ku #lymsm
The crazy case of a #T-cell ALL that switched to acute myeloid leukemia shortly after #CART-cellTherapy targeting #CD7. #Myeloid switch could be a new escape mechanism of leukemia under the pressure of targeting CD7.
https://t.co/99fQeqnofR