Paul Richardson, MD, discusses the baseline characteristics of the patients with relapsed/refractory multiple myeloma enrolled in the CC-92480-MM-002 trial.
Paul Richardson, MD, director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute in Boston, Massachusetts, RJ Corman professor of medicine at Harvard Medical School, discusses the baseline characteristics of the patients with relapsed/refractory multiple myeloma enrolled in the CC-92480-MM-002 trial (NCT03989414).
0:09 | Now in terms of the actual design, I just showed them here to help simplify it because there's a fair amount of complexity to these designs. As you can see, this in the top was B1, the classic 3 weeks on 1 week off. The goal of B2 was 2 weeks on 1 week off. As I mentioned, B3 has this interesting syncopated design, so 7 days on 7 days off, 7 days on, 7 days off, and then once they move beyond cycle 6, we move to 3 weeks on, 1 week off. The goal here was to sort of provide a platform for better understanding optimal tolerance of mezigdomide [CC-92480] and dosing in the setting of combination strategies with antibodies.
0:49 | And importantly, when we combine mezigdomide with elotuzumab [Empliciti]. we sought here rather simple approaches, just basically 3 weeks on, and 1 week off. The primary end points were to establish the recommended phase 2 dosing, and also to establish preliminary efficacy as well as safety. Then the secondary end points included the overall duration of response and exploratory aspects, including both pharmacodynamics and pharmacokinetics.
1:15 | These are the baseline characteristics of the patients. In fact, there were 79 patients in all in this study, to date, and what you have here is 59 patients in the daratumumab [Darzalex] cohort, and 20 patients in the elotuzumab cohort. As you can see, our oldest patient in the daratumumab platform was 83. Remarkably, our oldest patient in the elotuzumab cohort was 91. You can see here that we had an enrichment of high-risk cytogenetics with over 40% in both groups.
1:46 | Now, what about refractory status? Well, obviously in the context of the daratumumab-exposed patients, they could be daratumumab-exposed, but they shouldn't be daratumumab-refractory. So in the daratumumab cohort, we had double refractoriness for sure, with primarily the extensive exposure to [proteasome inhibitors] as well as lenalidomide [Revlimid] and pomalidomide [Pomalyst]. But obviously, our patients could not be dara-refractory to enter. In contrast, that elotuzumab treated patients were, and as you can see here, they were enriched for a triple-class refractoriness.
2:25 | Now, in terms of treatment disposition and treatment exposure, this is summarized here, and you can see that the most mature cohort is actually cohort B1 for the daratumumab treatment arm. B2 is less mature, and B3 is a little bit more mature than B2, but still way behind B1. What's important to share in terms of discontinuations is that the vast majority of these were due to progressive disease. Actually, very few were due to adverse events, which I think is an important positive.