Oncology/Hematology > > Myeloma– Cilta-cel, ide-cel win assistance in spite of issues about early death threat
by Charles Bankhead, Senior Editor, MedPage Today March 16, 2024
2 CAR T-cell treatments for several myeloma won beneficial suggestions for earlier usage in the illness throughout a day-long conference of the FDA Oncologic Drugs Advisory Committee (ODAC).
By an 11-0 vote, ODAC advised that FDA authorize ciltacabtagene autoleucel (cilta-cel, Carvykti) for usage as second-line treatment in particular clients with myeloma. Later on in the day, the panel voted 8-3 in favor of authorizing idecabtagene ciloleucel (ide-cel, Abecma) for second-line treatment. The FDA is not bound by advisory committee choices however typically follows the suggestions.
The beneficial suggestions followed significant conversation about an early death danger– and the prospective cause– seen in critical trials of both treatments. In the end, the ODAC panel discovered that the advantages of earlier usage of the treatments exceeded the danger.
“The information from CARTITUDE-4 [the cilta-cel pivotal trial] are still rather immature, however it seems beneficial in its totality at this time,” stated ODAC chair Ravi Madan, MD, of the National Cancer Institute in Bethesda, Maryland. “While the danger of sudden death, frequently previous to treatment, is not disregarded in this conversation or this vote, it does appear to be surpassed by the long-lasting prospective advantages here.”
“Ideally, focus in the more advancement of this treatment might be put in much better understanding how to enhance bridging treatment and defending against infection,” he included.
The panel discovered the information for ide-cel a little less engaging, not even if of the early death threat however by the absence of survival advantage in the essential KarMMa-3 trial, in spite of a big progression-free survival (PFS) benefit for the CAR T-cell treatment.
“The dangers are that PFS– [based on] the information we have now– appears short-term and there is no clear advantage that early is much better than later on,” stated Daniel Spratt, MD, of the UH Seidman Cancer Center in Cleveland, who cast among the “no” votes. “Those that do cross over had beneficial OS [overall survival]so there’s not a clear advantage of earlier intervention. There are numerically higher sudden deaths. I still think there doubts capacity of even worse OS that crossover does not describe, however we do not have all of the occasions.”
“Speaking to real-world information, I believe there’s an entire opposite where companies would require to inform their clients, based upon this information, there’s possibly over a half-million-dollar cost for an absolutely no day, usually, life got over a 31-month duration,” Spratt continued. “My vote is based upon the follow up we have today. I believe with longer follow-up, it might alter the PFS curves coming together, along with the OS. I would highly motivate market to show a legitimate surrogate endpoint for their client information to determine this.”
Jorge Nieva, MD, of the USC Norris Comprehensive Cancer Center in Los Angeles,