Trailblazer KRAS treatment filed with the FDA

From: PharmaPhorum

Amgen has filed its trailblazer KRAS inhibiting drug treatment with the FDA for a group of lung cancer patients with an aggressive form of the disease.

The drug was the first targeted at the mutation known as KRAS to show activity in the clinic and provided the biggest talking point at the American Society of Clinical Oncology (ASCO) conference in 2019.

Since then Amgen has been gathering evidence to support a filing in a group of patients with advanced or metastatic KRAS G12C mutated non-small cell lung cancer.

The FDA is reviewing sotorasib under its Real-Time Oncology Review (RTOR) programme and could be the first to be approved in this indication, which covers around 13% of NSCLC patients.

Amgen’s filing is on track with a schedule laid out at the beginning of the year, following a top-line read out from a phase 2 trial in October.

These results came from the CodeBreaK 100 clinical study, which tested the drug in patients whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy.

In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile, Amgen said, although detailed results have yet to be announced.

Full results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium next month.

KRAS is a target that has long evaded pharma companies but early trial results in solid tumours at ASCO led to a round of deal-making involving rivals.

Mirati, a biotech from California, specialises in drugs targeting KRAS and is a step behind Amgen with its rival adagrasib.

Novartis signed a deal to evaluate Mirati’s drug soon after ASCO and Merck & Co and Boehringer Ingelheim are among those who have signed KRAS deals.

Although it looks like the molecules developed so far will work only in lung cancer, rather than the wider range of cancers with KRAS mutations, there is hope the drug will provide a new treatment option for an aggressive and deadly form of the disease.

David Reese, executive vice president of Research and Development at Amgen, said: “Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harbouring the KRAS G12C mutation.”