Journal of Clinical Oncology Publishes Rapid Communication Featuring Updated Clinical Data for Adagrasib as a Targeted Treatment for KRASG12C-Mutated Advanced Solid Tumors

Mirati Therapeutics, Inc., a commercial stage biotechnology company, announced the Journal of Clinical Oncology published in a Rapid Communication data indicating adagrasib, a potent and selective KRAS inhibitor, is well tolerated and demonstrates meaningful clinical activity in patients with pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), and other solid tumors harboring a KRAS^G12C mutation. Rapid Communications are reserved for publications deemed to represent timely and late breaking research that may have an immediate impact on patient care.

In addition, findings were presented last week at the April session of the American Society of Clinical Oncology (ASCO) Plenary Series Program. This publication follows the recent inclusion of KRAZATI (adagrasib) in the National Comprehensive Center Network (NCCN) Guidelines for Central Nervous System (CNS) Cancers for patients living with previously treated KRAS^G12C-mutant non-small cell lung cancer (NSCLC) and CNS metastases.

The Phase 2 data of the KRYSTAL-1 study demonstrates the potential of adagrasib as a monotherapy in patients with unresectable or metastatic KRAS^G12C-mutated solid tumors beyond NSCLC and colorectal cancer (CRC). The data presented was based on confirmed blinded, independent, central review (BICR) responses. This is the largest Phase 2 dataset evaluating KRAS G12C mutated solid tumors other than non-small cell lung cancer and colorectal cancer.

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The enrolled and treated population (n=63) included 21 PDAC, 12 BTC, 9 appendiceal adenocarcinoma, 4 gastroesophageal/esophageal adenocarcinoma, 3 small bowel adenocarcinoma, 5 ovarian adenocarcinoma, 4 unknown primary, 3 endometrial adenocarcinoma, 1 breast adenocarcinoma and 1 glioblastoma. The median prior lines of systemic therapy was two.

These findings demonstrate a meaningful improvement relative to the historically reported standard of care for PDAC and BTC. For patients with previously treated metastatic PDAC, current standard of care has resulted in limited ORR (3-16%). In a biomarker-unselected BTC patient population, the ABC-06 phase 3 trial investigating FOLFOX in the second-line setting reported an ORR of 5%.

“We are thrilled to see the results of this Phase 2 study, which demonstrate a marked improvement on the current standard of care for patients with unresectable or metastatic KRAS^G12C-mutated solid tumors, including PDAC, BTC, other gastrointestinal (GI) and non-GI tumors, where few treatment options exist.

SOURCE: PR Newswire