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JPM: Takeaways for ASH 2019Bristol (BMY) – An Overall Positive Set Of Updates From ASH increasingly competitive. On Friday, BMY / bluebird announced positive Phase 2 KarMMa study results for bb2121 in relapsed and refractory multiple myeloma with the high dose achieving an 81.5% ORR, a 35.2% CR rate (N=54) and a tolerable safety profile largely in-line with the prior Phase 1 study. Overall, we view the data as broadly in-line with Street expectations with both response rates and duration of therapy holding up despite a more severe refractory patient population enrolled. Looking forward, we expect an FDA filing for bb2121 near-term (one of three products tied to CELG CVR) although the longer-term competitive landscape remains TBD. JCAR017 (liso-cel), BMY reported solid pivotal Phase 1 for the TRANDSCEND-NHL-001 study in the relapsed and refractory large cell lymphomas with strong efficacy (73% ORR, 53% CR rate in heavily pre-treated population) and a robust safety profile (low CRS rate at 2%, NE rate of 10%). Overall, BMY reiterated expectations for a liso-cel FDA filing before year-end while highlighting a significant opportunity to transform a thus far disappointing r/r NHL CAR-T commercial market with the potential for outpatient drug administration to expand over time (lower patient burden, potential reimbursement benefits). the first clinical study of CC-93269, a bi-specific t-cell engager antibody (TCE), in the r/r MM setting. In the Phase 1 dose- escalating study, the high dose of CC-93269 achieved an ORR rate of 88.9% and CR rate of 44.4% (N=21), which presents a competitive profile versus later stage BCMA CAR-T therapies, particularly when accounting for a significantly less demanding product manufacturing process. With a highly favorable profile from Phase 1 results, we see CC-93269 as one of BMY’s mostinteresting early stage assets and the company plans to move the asset into registrational study near-term. |
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