Recently, Amgen (NASDAQ: AMGN) announced that the FDA (Food and Drug Administration) has granted the company’s investigational KRASG12C inhibitor, Sotorasib, Breakthrough Therapy designation for the treatment of locally advanced or metastatic non-small cell lung cancer with the KRAS G12C mutation. This was determined by an FDA-approved test, following at least one previous systemic therapy.
“For more than four decades, scientists have attempted to target KRAS. Amgen’s update is welcome news for the many non-small cell lung cancer patients afflicted with the KRAS G12C mutation. Currently, these patients have no targeted therapies,” commented Bonnie Addario, board chair and co-founder of the GO2 Foundation for Lung Cancer. “We’re pleased that Amgen and the FDA acknowledge the unmet need for these cancer patients and are working on new cancer treatment options as quickly as possible.”
KRAS G12C is the most common KRAS mutation in non-small cell lung cancer. Around 13% of patients in the U.S. with non-small cell lung cancer (NSCLC) adenocarcinoma have the KRAS G12C mutation. Every year in the US, approximately 25,000 new patients are diagnosed with KRAS G12C-mutated non-small cell lung cancer.
Unmet need is high, and patients with NSCLC have limited options. Moreover, NSCLC patients with the KRAS G12C mutation, have failed to respond to first-line treatment. The bottom line is, the outcome with current therapies is less than optimal, with positive response rates of just 9-18%. The median progression-free survival rate is approximately 4 months for second-line non-small cell lung cancer.
Amgen has tackled one of the hardest challenges in cancer research during the last 40 years by developing Sotorasib. Sotorasib is the first KRASG12C inhibitor to enter the clinic. The new cancer treatment is being studied in a very broad clinical program, testing 10 combinations at clinics spanning four continents. In little more than two years, the Sotorasib clinical program has also developed the deepest clinical data set, analyzing over 600 patients across 13 different tumor types.
“Breakthrough Therapy designation followed by Real-Time Oncology Review brings Amgen even closer to possibly providing a targeted therapy to cancer patients with a KRAS G12C mutation. Sotorasib could become the foundational therapy in KRAS G12C-driven cancers,” said David Reese, M.D., Amgen’s executive vice president of Research and Development. “We are happy to receive these regulatory designations and Amgen plans to apply for approval for the new drug by end of the year. We’re quickly working to get Sotorasib to the patients who need it.”
A Breakthrough Therapy designation can expedite the development and regulatory review of drugs that might demonstrate a substantial improvement on a clinically significant terminus over available drugs. A Real-Time Oncology Review is a pilot program designed to examine more efficient review processes that ensure effective and safe treatments, made available to patients as soon as possible.
These designations are supported by positive Phase 2 results in advanced, non-small cell lung cancer patients from the CodeBreaK 100 clinical study. These patients had cancer that progressed despite previous treatment with immunotherapy and/or chemotherapy. During the study, cancer treatment with Sotorasib provided long-lasting anticancer activity and a positive benefit-risk profile.
CodeBreaK is a clinical development program designed for Amgen’s investigational drug Sotorasib. The clinical program is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation. Furthermore, the CodeBreaK addresses the long-standing unmet treatment need for these types of cancers. To date, CodeBreaK is the most advanced KRAS G12C clinical development program, with more than 600 enrolled patients and 13 different types of tumors.
Phase 1 and 2, CodeBreaK 100, represents an open-label, first-in-human, multicenter study, enrolling cancer patients with KRAS G12C-mutant solid tumors. Patients eligible for CodeBreaK must have received a previous line of systemic anticancer therapy, accordant with their type of tumor and the stage of their disease. The main terminus for the Phase 2 study is a centrally assessed objective response rate. The Phase 2 trial enrolled 126 NSCLC patients, and 123 of those had centrally evaluable lesions by RECIST at baseline. Also, the Phase 2 trial is fully enrolled for colorectal cancer and topline results should be out by 2021.
CodeBreaK 200 is a planned global Phase 3 randomized active-controlled study comparing Docetaxel to Sotorasib in patients with KRAS G12C-mutated non-small cell lung cancer. That study is currently recruiting. Amgen also has CodeBreaK 101, an assortment of Phase 1b combination studies spanning a variety of advanced solid tumors. CodeBreaK 101 is open for enrollment.
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