A targeted oncology company, Mirati Therapeutics, Inc. (NASDAQ: MRTX) jumps over 15.43% in early trading session on Tuesday after the FDA has given expedited clearance to KRAZATI (adagrasib), a targeted therapeutic option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as established by an FDA-approved test, who have undergone at least one previous systemic therapy.
The CEO, Mirati Therapeutics, Inc., David Meek stated that the FDA approval of KRAZATI is a significant step forward for thousands of patients who have KRASG12C mutations, including roughly 14% of patients with NSCLC adenocarcinomas histology who have a KRASG12C mutation. Mirati is overjoyed to be able to provide KRAZATI in tablet form to patients in the United States with advanced NSCLC who have progressed beyond a first-line therapy for the notoriously difficult-to-treat KRAS mutation.
He added, “We look forward to continuing to advance our KRAZATI development program including several monotherapy and combination studies in KRASG12C-mutated solid tumors.”
Based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg capsules administered orally twice daily in 116 patients with KRASG12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor, KRAZATI has been granted accelerated approval. The major efficacy outcomes, ORR and DOR, were validated by blinded independent central review (BICR) using response assessment criteria in solid tumors (RECIST v1.1).
In a pooled efficacy analysis (n=132) of Phase 1/1b NSCLC and registrational Phase 2 NSCLC cohorts from the KRYSTAL-1 study evaluating adagrasib as a single agent at 600 mg capsules orally twice daily, adagrasib demonstrated an ORR of 44% and a disease control rate of 81% based on BICR, a median DOR of 12.5 months (95% CI, 7.3-NE
KRAZATI’s safety profile was examined in 366 patients participated in the KRYSTAL-1 and KRYSTAL-12 trials as a single drug at 600 mg orally twice daily in a pooled patient group with NSCLC and other solid tumors. Nausea, diarrhea, vomiting, exhaustion, musculoskeletal discomfort, hepatotoxicity, renal impairment, edema, dyspnea, and reduced appetite were the most prevalent (25%) side effects. KRAZATI was discontinued permanently in 13% of patients due to an adverse response.
Although KRASG12C is the most frequent KRAS mutation in NSCLC, patients have had few therapy choices for this distressing and difficult-to-treat disease. 2,3
“KRAZATI’s approval provides an effective treatment for individuals with advanced NSCLC who have the KRASG12C mutation. Positive ORR and DOR results in previously treated patients with NSCLC harboring the KRASG12C mutation show the efficacy of KRAZATI as a treatment option for these difficult-to-treat patients “Shirish M. Gadgeel, MD, chief of the Division of Hematology and Oncology, Department of Internal Medicine, Henry Ford Cancer Institute/Henry Ford Health System, made the announcement.
