Daratumumab is now FDA and EU approved for treatment of high risk smoldering myeloma.
It is recommended level 1 by NCCN. My thoughts:
In the AQUILA randomized trial, daratumumab:
-Prolonged time to active myeloma
-Prolonged time to end organ damage
-Delayed time to needing active myeloma therapy
-Improved overall survival
-Improved PFS-2
-Low toxicity
-No detriment to QOL
This is a limited duration (3 years) therapy. This limited duration therapy can prevent or delay full blown typically continuous myeloma therapy by years. Full myeloma therapy is not simple. It involves 4 drug initial therapy, stem cell transplant in eligible patients, and prolonged 1-2 drug maintenance. Delaying time to full myeloma therapy by a long time is in and of itself a big deal.
Watching patients closely and starting therapy only when you see evidence of progression sounds good on paper but in reality will lead to more patients starting full myeloma therapy sooner. It also risks end organ damage between visits. Experts think they can watch carefully but in studies we find progressions are missed at top centers. In real world the type of follow up we did in AQUILA will not be possible. Patients with active myeloma in my experience are struggling to see their doctors in time.
We hope to have more overall survival information soon. But we already see an important improvement.
For more on the trial see https://t.co/3hC2E6tnxQ
Durability and disease control define DeLLphi-303 results—
Tarlatamab + chemoimmunotherapy achieved 71% ORR and 11-mo DOR in ES-SCLC, with nearly 50% of patients still responding at cutoff.
#ESMO25 coverage: https://t.co/fzmQlCAHdk
📈 DeLLphi-304: Tarlatamab Boosts OS vs Chemotherapy in SCLC
Median OS reached 10.9 mo with tarlatamab vs 6.4 mo with chemo (CFI <90 d); OS benefit seen across all CFI and PD-(L)1 subgroups.
Full results ➜ https://t.co/aPD4QVjynQ
Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating pembrolizumab (PD1 inhibitor) met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive #urothelialcarcinoma (MIUC) and locally advanced urothelial carcinoma versus observation. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery-other dual primary endpoint of overall survival (OS) is pending. The safety profile of pembro in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities. Honored to participate as @SWOG Principal Investigator -congrats to overall Principal Investigator @apolo_andrea @NCICCR_UroOnc and colleagues from @ALLIANCE_org@eaonc! @OncoAlert@urotoday @practiceupdate @themednet@GUOncologyNow@BladderCancerUS
https://t.co/TK0JduygEg
My prediction in 2012 for the next 25 yrs.
1. KRAS will be druggable
2. ABVD will be replaced.
3. Precision oncology will change Lung cancer Rx.
4. Sarcoma will be 1000’s of diseases.
5. Anaplastic thyroid cancer will be treatable
👇🏼 in Hodgkin’s :) not even a decade.
The head of the United States Food and Drug Administration (!) @SteveFDA does not understand the difference between relative and absolute risk reduction -- a basic, fundamental concept in medicine, statistics and clinical trial interpretation. It just gets worse and worse.😢