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Colorectal cancer | News | Media | Updates

April 08, 2024

Krazati plus cetuximab showed improvement in objective response rate in patients with KRASG12C-mutated CRC

Mirati Therapeutics, a Bristol Myers Squibb company, disclosed findings from segments of the Phase 1/2 KRYSTAL-1 study exploring Krazati (adagrasib) alongside cetuximab for managing patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).


With an average monitoring period of 11.9 months among 94 subjects, the Krazati-cetuximab combination displayed a noteworthy objective response rate, the primary metric, at 34%. Moreover, it boasted a median progression-free survival of 6.9 months and a median overall survival of 15.9 months in pre-treated individuals with KRASG12C-mutated locally advanced or metastatic CRC. The median duration of response stood at 5.8 months, with disease control observed in 85% of cases. The safety profile of Krazati plus cetuximab proved manageable and consistent with prior observations, aligning with the known safety profiles of each drug independently.


KRASG12C mutations, functioning as oncogenic drivers, are prevalent in approximately 3-4% of colorectal cancers. Previous investigations indicated that cetuximab monotherapy failed to yield clinical benefits among patients with KRAS-mutated colorectal cancer.


In February 2024, the company disclosed that the FDA had greenlit a supplemental new drug application for Krazati in conjunction with cetuximab as a targeted therapy for individuals with previously treated KRASG12C-mutated locally advanced or metastatic CRC, setting a priority review with a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.

 

May 23, 2022

Seagen announced cORR in Phase 2 clinical trial of Tukysa plus trastuzumab.

Seagen has announced the Phase 2 MOUNTAINEER clinical trial, which evaluates the efficacy of Tukysa (tucatinib) in combination with trastuzumab in adult patients with HER2-positive metastatic colorectal cancer (mCRC). Seagen announced that this clinical trial would become the basis for the supplemental New Drug Application to the US Food and Drug Administration.

MOUNTAINEER is a Phase 2 clinical trial that enrolled 117 patients with HER2-positive metastatic or unresectable colorectal cancer. The primary endpoint was confirmed objective response rate, 38.1% of patients showed cORR. The median duration of response was 12.4 months.


 

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