Oct. 2 Quick Takes: Takeda withdrawing Exkivity after confirmatory miss

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) said it intends to withdraw tyrosine kinase inhibitor Exkivity mobocertinib from the market after it missed the primary endpoint of the Phase III EXCLAIM-2 study to treat EGFR exon 20 insertion mutation-positive non-small cell lung cancer in a first-line setting. FDA had granted accelerated approval to Exkivity in September 2021 based on surrogate endpoint data from a Phase I/II trial in platinum-pretreated patients. Exkivity is an inhibitor of EGFR and HER2. EGFR exon 20 insertions produce a conformational change in the receptor’s intracellular domain that renders tumors insensitive to traditional TKIs.

With new data from the Phase III APPLAUSE-IgAN study showing that CFB inhibitor iptacopan led to significant reductions in proteinuria among patients with IgA nephropathy, Novartis AG (SIX:NOVN; NYSE:NVS) plans to discuss the trial’s results with FDA with the aim of a regulatory submission. The product would compete with Filspari sparsentan from Travere Therapeutics Inc. (NASDAQ:TVTX) and Tarpeyo budesonide from Calliditas Therapeutics AB (SSE:CALTX; NASDAQ:CALT), each of which has accelerated approval based on the surrogate proteinuria endpoint; Novartis said APPLAUSE-IgAN will continue toward a 2025 readout on the primary endpoint, measuring estimated glomerular filtration rate at 24 months...