Deepu Madduri, MD, on the Implications of the Phase 1b/2 CARTITUDE-1 Trial Results

Preliminary results from the phase 1b/2 CARTITUDE-1 trial (NCT03548207) presented at the 62nd Annual ASH Annual Meeting & Exposition indicated that a single low-dose infusion of ciltacabtagene autoleucel (cilta-cel; JNJ-68284528) led to early, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma.

In addition, the safety profile of cilta-cel in this patient population was found to be consistent with that observed in the phase 1 LEGEND-2 study in China. Based on these findings, further investigation of cilta-cel in other populations of patients with multiple myeloma are already underway.

In an interview with CancerNetwork®, Deepu Madduri, MD, assistant professor of Medicine (Hematology and Medical Oncology), associate director of Cellular Therapy Service, and director of Clinical Operations with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai, spoke about the implications of these study results.

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We know that these patients [who] were enrolled on this study were heavily pretreated because [the median number of] prior lines of therapy [was] 6, in a range anywhere from 3 to 18. And these patients were also very refractory; 99% of these patients were actually refractory to their last line of therapy, 88% were triple-class refractory, and 42% were penta-refractory. Understanding that we have this refractory, heavily pretreated patient population in myeloma, we know the median overall survival is less than 12 months. To offer this one-time treatment and [see] that we haven’t reached the median [progression-free survival; PFS] is quite encouraging. And we’re hoping with longer follow-up data [that] we can see what the median PFS is, and it’s really great to see that we have some therapy that we can offer our patients at this time.