After Midnight here on the coast, awoke with my mind working over time about Immutep and cancer. I have just had some reconstructive plastic surgery as a result of skin cancer removal from the tip of my nose. Got me thinking alot lately, nothing dangerous for me, however, a little disfiguring and a more relevant topic for me just now.
Long overdue official feedback from the FDA considering it has been 12 months since the AIPAC Final Phase 2b Data was embargoed for ASCO 2021. I just hope it doesn't take another 12 months to design the trial and appoint a suitable financial partner?
However, are Immutep MGMT asking themselves the question? Is it worthwhile to continue pursuing Efti in Phase3 AIPAC as a monotherapy in MBC when checkpoint inhibitor adjuvent treatments appear to be the future? Should the Phase3 AIPAC trial if/ being designed include an adjuvent arm such as EFTI/ Keytruda or EFTI/ Opdivo? I personally think the funds would be better spent in adjuvent settings for that is where a standard of care to replace chemotherapy will be achieved. Look at the results when PD-1 and Lag3 are combined, look at the safety profile in comparison to chemotherapy. After Relativity-047 is FDA approved, the game has changed perhaps the clinical strategy for Immutep does too?
My laymans point is Optivo and Keytruda are defunct as stand alone therapies in comparison to when Lag3 is coupled as an adjuvent with same. The exposed results to date show the synergy between Opdivo or Keytruda when coupled with Lag3 to be Omnipotent.
Hence, I believe like many others here, the FDA will grant approval to BMS based on their Relativity-047 Clinical Trial at the end of this month. In doing so Lag3 the newest checkpoint inhibitor becomes FDA validated. (The first FDA validated checkpoint inhibitor advancement in nearly 8 years I believe?) There are quicker and financially more efficient ways for this little Aussie beauty of a company to get to market than AIPAC Phase3 in MBC. IMO. Is it so important to validate EFTI as a sub group monotherapy in MBC right now? No disrespect or malice to anybody staff or patients.
Relatlimab Plus Nivolumab a 'Game Changer' in Advanced Melanoma
Megan Brooks
January 05, 2022
For untreated advanced melanoma, the fixed-dose combination of relatlimab and nivolumab is a "game changer that we have been waiting 10 years for," Hussein Tawbi, MD, PhD, University of Texas MD Anderson Cancer Center, Houston, told Medscape Medical News about today's publication of the phase 2/3 RELATIVITY-047 trial.
Progression-free survival (PFS) was "essentially double" with the relatlimab-nivolumab combination vs nivolumab alone, Tawbi said. "We were always excited about the relatlimab-nivolumab combination…but I didn't expect it to be this good.
Furthermore, a significant point of focus is that Lag3's emergence through the clinical trial setting looks incredibly timely when considering Opdivo and Keytruda's patent expiry dates as monotherapies. My personal interpretation is that Lag3 is the adjuvent ace that BMS and MERCK require to hold their distinct market advantage into the future and beyond the relevant monotherapy patent expirations. Hence one of the reasons why adjuvents are the future focus of both companies plus Roche, not only because they are proving superior in the clinic but patent expiry relevance as montherapies also.
DYOR IMO Good Luck to ALL Patients & LTH.
Ps. Immuteps CFO Dr Freddy Triebel is about to recieve the FDA Validation/ Clinical recognition he rightly deserves for his Magical 1990's Lag3 Discovery. What an enormous contribution Dr Triebel has made for over 30 years to the good of humanity, very inspirational stuff Doc.
My prediction is that Dr Triebel is a future Nobel Prize recipient in waiting.
Pss. I am not a medical professional and the above should be ignored. But to me AIPAC is the long hard road when all MBC patients not only the sub groups will be recieving PD-1/ Lag3 adjuvent therapy as replacement for chemotherapy standard of care pre and post surgery within 5 to 10 years. AIPAC is not required right now to prove Lag3's significance/ importance in the broader sense once Relativity-047 nails approval. Is it? The iron looks hot on adjuvents, partnerships appear to be the only way forward to me.
IMM Price at posting:
40.0¢ Sentiment: Buy Disclosure: Held
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