BMS’s KRAS inhibitor KRAS inhibitor greenlit by FDA for colorectal cancer

2024-06-21

上市批准优先审批临床3期ASCO会议加速审批

The FDA on Friday granted accelerated approval for Bristol Myers Squibb’s KRAS inhibitor Krazati (adagrasib) in combination with cetuximab to treat patients with KRASG12C-mutated, locally advanced or metastatic colorectal cancer (CRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The pharma gained Krazati through its $5.8-billion purchase of Mirati Therapeutics last year.

The clearance was based on data from the Phase I/II KRYSTAL-1 study, in which Krazati achieved a confirmed overall response rate of 34% in 94 patients with CRC. Additionally, the cohort experienced a median duration of response of 5.8 months.

Friday’s win in CRC, which follows a priority review, may boost confidence in the drug as it faces somewhat uncertain prospects on its next milestone – earning full approval in lung cancer, an area where KRAS inhibitors KRAS inhibitors have struggled to succeed. For more, see Vital Signs: Do KRAS blunders weigh down targeted therapy in lung cancer?

Krazati first scored accelerated approval in patients with KRAS-mutant locally advanced or metastatic non-small-cell lung cancer (NSCLC) in 2022, and a March readout of the Phase III KRYSTAL-12 seemed to support the drug’s use in the setting, with BMS reporting that it met the primary endpoint of progression-free survival (PFS).

However, detailed data for the confirmatory trial shared earlier this month at the American Society of Clinical Oncology (ASCO) annual meeting revealed the endpoint’s specific figures, potentially muddying the waters on what had earlier appeared to be a straightforward win.

Krazati achieved a PFS of 5.49 months compared with 3.84 months for chemotherapy, a statistically significant and clinically meaningful improvement. However, ahead of the read-out, TD Cowen analysts suggested the drug would need to delay cancer progression by about 4 months relative to docetaxel to be considered a success.

For more analysis on the data, see ASCO Daily: Analysis and insight from Saturday's key presentations – BMS's Krazati adds another underwhelming KRAS datapoint.

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