China’s Regulator Accepts Amgen’s Sotorasib for Breakthrough Therapy Designation as a First Milestone

China’s Regulator Accepts Amgen’s Sotorasib for Breakthrough Therapy Designation as a First Milestone

Amgen, a leading global biotech company based in Southern California reported a first—the first time it has successfully achieved Breakthrough Therapy Designation (BTD) status by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). In conjunction with its BeiGene partnership, the designation is for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is a big milestone as NSCLC is the most common form of lung cancer representing 80-85% of all cases worldwide. KRAS G12C is the most common KRAS mutation in NSCLC. The mutation is a biomarker of poor prognosis in Chinese NSCLC patients, which may be improved G12C-specific inhibitors. Amgen reports in their recent press release that about 3-5% have the KRAS G12C mutation found mostly in smokers. Smoking in China still represents a major problem, with an estimated 350 million smokers.

About Sotorasib?

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, the first KRASG12C inhibitor to enter the clinic. Sotorasib is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years, the sotorasib clinical trial program has also established the deepest clinical data set with nearly 700 patients across 13 tumor types.

What supports the BTD status in China?

The Breakthrough Therapy Designation is supported by the positive CodeBreaK 100 Phase 2 results in patients with advanced NSCLC whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib demonstrated durable anticancer activity with a positive benefit-risk profile. These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium from 3:50-4PM PST recently on Friday Jan. 29.

BTD Process—Opportunity for sotorasib as first potential treatment

The NMPA’s BTD process is designed to expedite the development and review of therapies that are intended for the prevention or treatment of serious life-threatening diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options. This designation shows the potential for sotorasib to become the first targeted treatment available in China for KRAS G12C-mutated NSCLC.

About CoreBreak

The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled nearly 700 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer is fully enrolled and topline results are expected in 2021.

Moreover a global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreak 200) is currently recruiting participants. Amgen also reports over 10 Phase 1b combination studies across various advanced solid tumors (CodeBreak 101) open for enrollment.

About Amgen

Amgen’s oncology group can be reviewed here. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.