Amgen sees no 'significant delays' from pandemic to novel KRAS cancer drug

Amgen
(Business Wire)

Amgen has become the latest biopharma to try to figure out the hit it may take to its pipeline timings amid the COVID-19 pandemic.

In what may be a relief for some investors, its big, highly anticipated KRAS drug AMG 510 is already fully enrolled, and the company doesn’t see any “significant delays” for results here. (Though that line doesn’t rule out any smaller delays.)

The biopharma is currently undertaking a “potentially pivotal” phase 2 for the KRAS inhibitor in certain lung cancer patients and has high hopes this med (which was one of the most talked about targets of 2019) will continue on its clinical path relatively uninterrupted.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

The same goes for the tezepelumab phase 3 asthma study, which is partnered with AstraZeneca, and the omecamtiv mecarbil phase 3 heart failure study, which is being worked on alongside Cytokinetics.

These, too, are fully enrolled, and thus, Amgen said, “we do not anticipate significant delays in obtaining results.”

RELATED: Amgen's KRAS drug continues to deliver but faces 'curse' of high expectations

But delays could still hit the biopharma. It said an “increasing number of clinical trial sites are restricting site visits and imposing restrictions” on new trials as well as patient visits to limit COVID-19 exposure.

Given this, it said it is making decisions “study-by-study” and “country-by-country” but has already temporarily paused enrollment/screening in clinical trials “where there is uncertainty around the ability of sites to ensure subject safety or data integrity at the present time.”

Amgen will allow patients to join studies where there is the potential for “significant benefit in a serious or life-threatening condition” and where site resources allow new patients to be safely enrolled and closely monitored.

It added: “We are actively implementing remote and local procedures per recent FDA guidance and working with investigators for appropriate care of these patients in a safe manner consistent with agency guidelines.”

Suggested Articles

A COVID-19 antibody diagnostic developed through a joint venture between Mount Sinai Health System and RenalytixAI has been authorized by the FDA.

Researchers at Northwestern University have trained an AI algorithm to automatically detect the signs of COVID-19 on a basic X-ray of the lungs.

Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously.