The Kochenderfer study for CAR-19 published in the Journal of Clinical Oncology showed 12 months' median duration of complete response, suggesting positive read-through generally speaking for Kite Pharma Inc.’s (NASDAQ:KITE) ZUMA-1. Importantly, 11 of 12 complete responses (CRs) are still ongoing, suggesting the potential for very long-term remission. Canaccord believes the CAR-19 data suggest that KTE-C19 is a favorable option for NHL patients with few, if any, other treatment options, which may provide long-term potentially curative benefit.
Canaccord believes the Median Overall Survival of ~24 months in the Kochenderfer study compares favorably to the ~6.6 months KITE showed in historical data from SCHOLAR-1. Importantly, the median Overall Survival for patients with ongoing complete responses could ultimately be longer than ~24 months for the overall population.
Safety for CAR-19 was similar to KTE-C19, with ~55% reporting grade 3/4 neurologic toxicities, but no deaths. Importantly, only two patients received the IL-6 antagonist tocilizumab, and one patient received dexamethasone. All acute toxicities resolved completely, which Canaccord views as very important, especially for neurologic toxicity.
Canaccord maintains its BUY rating and raises its PT to $90 from $75, based on its expectations for US FDA approval for KTE-C19 in advanced DLBCL during 2017, the recent equity raise for KITE, and higher probability of approval for indications outside of DLBCL. Canaccord believes the commercial launch for KTE-C19 is highly dependent on careful safety counseling by KITE to treating physicians, securing experienced advocates at major treatment centers, ensuring treatment referrals from community centers when KTE-C19 becomes appropriate.
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