#ASCO21: A week after nabbing priority review, Kite unveils the pivotal data it hopes will lead to a new CAR-T approval

2021-06-03

优先审批细胞疗法财报免疫疗法

Just less than a year ago, Gilead’s Kite won a landmark okay for its second CAR-T therapy, with data that former head of global development Ken Takeshita hailed as “better than Yescarta.” Now, ahead of #ASCO21, Kite is unveiling pivotal data to back the drug in a new type of cancer. Frank Neumann Of 55 patients who received Tecartus for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), 71% saw their signs of cancer disappear, new head of clinical development Frank Neumann said. However, some still had incomplete hematologic recovery (which the company defined as complete response with incomplete hematologic recovery, or CRi). Thirty-one percent of these patients saw ongoing responses at the data cutoff, Kite said, and 97% had deep molecular remission with undetectable minimal residual disease. “This patient population in particular has a very hampered hematopoietic system,” Neumann told Endpoints News. “I would say, for a patient reaching CRi in this particular indication, it’s fantastic, to say the least.” The data come from a primary analysis of the Phase II portion of Kite’s open-label ZUMA-3 trial. Just under half of the treated patients had received three or more therapies prior to Tecartus, and among the 25 who had taken the immunotherapy blinatumomab, the complete response rate was a bit lower, coming in at just 60%. Across the whole treatment arm, median duration of response, relapse-free survival and overall survival were 12.8 months, 11.6 months and 18.2 months, respectively. The FDA gave Tecartus priority review for the indication last Friday, and set a PDUFA date of Oct. 1. If approved, CEO Christi Shaw says the company could start rolling out the drug in days. The treatment comes with some risk, as 95% of patients experienced Grade 3 or higher adverse events, the most frequent being anemia and pyrexia, or fever. Grade 3 or higher cytokine release syndrome — a well-documented side effect of CAR-T therapy — occurred in 24% of patients. Neurologic events happened in 25%, Kite said. CRS and neurologic toxicities earned Tecartus a boxed warning in relapsed/refractory mantle cell lymphoma, though researchers saw lower cases of Grade 3 or higher CRS in that study than in ZUMA-3 (18% compared to 24%). CRS cases in Zuma-3 were “generally reversed with treatment,” Kite said in a statement. Two treatment-related deaths occurred in ZUMA-3, including one brain herniation and one case of septic shock, according to Kite’s statement. “The safety profile of Tecartus in this particular indication doesn’t differ significantly from what we’ve seen in other indications,” Neumann said. Upon its approval last year, a Kite spokesperson told Endpoints that the drug would be sold for $373,000. Since then, the list price has increased to just under $400,000, Shaw said. Tecartus brought in $31 million in Q1, as launch activities ramped up in the US, according to Gilead’s financial results. “As long as we have these really long durable responses, and we can manufacture consistently, and continue with Frank’s leadership developing new therapies that help increase the benefit/risk for patients, I think that’s the secret sauce,” she said. While ZUMA-3 enrolled patients 18 years and older, Novartis’ CAR-T rival Kymriah is already approved to treat relapsed/refractory ALL in patients 25 years old and younger, and it’s currently in a Phase III trial for high-risk ALL in the same population.

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