FDA Grants Breakthrough Therapy Designation to Sotorasib for NSCLC with KRAS G12C Mutation


The FDA granted breakthrough therapy designation to sotorasib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation, as determined by an FDA-approved test, following at least 1 prior systemic therapy.

The FDA has granted breakthrough therapy designation to the investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least 1 prior systemic therapy, according to Amgen, the developer of the agent.

The designation is supported by positive phase 2 results from the CodeBreaK 100 clinical study in patients with advanced NSCLC whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided patients with durable anticancer activity and a positive benefit-risk profile.

Notably, KRAS G12C is the most common KRAS mutation in NSCLC. In the US, about 13% of patients with NSCLC adenocarcinoma harbor the KRAS G12C mutation and each year approximately 25,000 new patients in the US are diagnosed with KRAS G12C-mutated NSCLC.

"Breakthrough therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers," David M. Reese, MD, executive vice president of Research and Development at Amgen, said in a press release. "We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it."

The first-in-human, open-label, multicenter, phase 1/2 CodeBreaK 100 study enrolled patients with KRAS G12C-mutant solid tumors. Patients deemed eligible for the study must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease.

The primary end point for the phase 2 portion of the study was centrally assessed objective response rate.

A total of 126 patients with NSCLC were enrolled, including 123 of whom had centrally evaluable lesions by RECIST at baseline. The phase 2 trial in colorectal cancer (CRC) is also fully enrolled and topline results are expected in 2021.

The CodeBreaK clinical development program for sotorasib is designed to treat a variety of patients with an advanced solid tumor with the KRAS G12C mutations. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.

A global phase 3 randomized active-controlled CodeBreaK 200 study comparing sotorasib to docetaxel (Taxotere) in patients with KRAS G12C-mutated NSCLC is currently recruiting. Amgen also has several phase 1b combination studies, titled CodeBreaK 101, across various advanced solid tumors open for enrollment.


Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation [news release]. Published December 8, 2020. Accessed December 8, 2020. https://www.prnewswire.com/news-releases/amgens-sotorasib-granted-breakthrough-therapy-designation-for-advanced-or-metastatic-non-small-cell-lung-cancer-patients-with-kras-g12c-mutation-301187803.html

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