Takeda touts positive first-line leukemia results — but isn't quite ready to reveal the hard data

2022-11-17

临床3期临床结果并购上市批准加速审批

Five years after shelling out more than $5 billion for Ariad Pharmaceuticals and its rare leukemia drug Iclusig, Takeda is setting plans in motion for a potential label expansion into the first-line setting — but for now, the pharma giant is keeping its cards close. Iclusig and reduced intensity chemotherapy successfully beat out Novartis’ Gleevec in treating newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in the Phase III PhALLCON trial, Takeda announced on Thursday. While researchers haven’t released any hard data, they did say that the open-label study met its primary endpoint by achieving higher rates of minimal residual disease (MRD)-negative complete remission (CR) compared to Gleevec. “It’s a large magnitude,” Awny Farajallah, Takeda’s global head of medical affairs for oncology, said in an interview. While declining to get into specifics, he added that more information is coming soon. If approved, Iclusig would be the first TKI available for patients in this front-line setting. “We are currently in the process of discussing with regulators on how we’re going to approach that, so the time frame is, it’s going to be very soon,” Farajallah said. Takeda’s stock $TAK was up about 1% on Thursday afternoon, pricing at around $13.92 per share. Iclusig won an accelerated approval back in 2012 to treat certain patients with Ph+ ALL and chronic, accelerated or blast phase chronic myeloid leukemia (CML) who have failed on or are intolerant to prior TKI therapy. A year later, the drug was briefly suspended over blood clot concerns, leading the FDA to require new safety warnings including a description of “arterial and venous thrombosis and occlusions that have occurred in at least 27% — more than one in every four — of patients treated with Iclusig,” the agency said at the time. A full approval came in 2016 based on two-year follow-up data, and Farajallah said those risks have been “extensively studied” and characterized on the drug’s label, adding that “we don’t see any further concerns with it as we move forward.” No new safety signals were identified in the PhALLCON trial, he said. In 2017, Takeda inked a deal to take over Ariad, Iclusig and the ALK-inhibiting lung cancer drug Alunbrig, and last year, Iclusig raked in ¥34.2 billion, or nearly $244 million. While Iclusig faces stiff competition from rivals such as Pfizer’s Bosulif and Novartis’ Scemblix, both approved in Ph+ CML, Farajallah stressed that a front-line win would add a “very unique indication” to the label. “There are currently no targeted therapies, as we’ve mentioned, that can be used in that first line and I think that is why we are excited about this,” he said.

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