Amgen's KRAS Inhibitor Shows Lukewarm Response In Lung Cancer Study

Amgen, Inc. AMGN shares were pulling back Monday following the presentation of new data on its investigational compound for solid tumors.

Good, But Not Good Enough

Amgen said in a Sunday statement that new data from the Phase 1 study of AMG 510 presented as an oral presentation at the IASLC 2019 World Conference on Lung Cancer, or WCLC, showed that out of the 13 of the evaluable patients receiving the target dose of 960mg once daily — the highest dose — seven, or 54%, achieved a partial response at one or more timepoints and six achieved stable disease.

Yet the 54% response rate pales in comparison to the 100% response rate from the first three patients that was reported by Amgen in June.

Nine of the 13 patients are continuing to take the daily pill, Amgen said. Of the partial responders, two died and another quit the study due to disease progression. One patient with stable disease also died.

AMG 510 is an investigational oral therapy selectively targeting the KRAS protein, and it is being evaluated in patients with previously treated KRAS G12C-mutated solid tumors.

The additional follow-up data presented at the WCLC conference was from a larger group of patients, including a subset of 34 non-small cell lung cancer, or NSCLC, patients, with 23 of the patients evaluable for efficacy.

"These new data reinforce the earlier positive response rate we shared at ASCO in more non-small cell lung cancer patients receiving AMG 510," said David Reese, the executive vice president of R&D at Amgen.

The company said there were no observed dose-limiting toxicities and no adverse events leading to discontinuation.

More Data In The Pipeline

Amgen said it will present additional data on AMG 510 at the European Society for Medical Oncology, or ESMO, 2019 Congress in Barcelona, Spain Sept. 27-Oct.1.

Data from a Phase 2 expansion study evaluating 960mg of AMG 510 is likely to be available next year, Vantage reported, quoting Greg Friberg, head of oncology at Amgen.

Amgen shares were down 2.74% at $202.03 at the time of publication Monday. 

Related Links:

The Week Ahead In Biotech: Conference Presentations, IPO News Flow Take The Spotlight

Biotech Stock On The Radar: Ardelyx Gears Up For FDA Decision Day