Amgen’s Lung Cancer Study Needs to Take a Breather

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Amgen Inc. (NASDAQ: AMGN) shares dropped on Monday after the firm released additional data from its early-stage lung cancer study. Specifically this data is coming from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated KRAS G12C-mutated solid tumors.

Separately, Eli Lilly had a surprising reaction to its lung cancer study results today.

The initial data from the Phase 1 study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this year. Overall the additional follow-up in a larger group of patients with non-small cell lung cancer (NSCLC) in this study continued to show anti-tumor activity with no dose-limiting toxicities.

The additional follow-up in a larger group of patients includes a subset of 34 NSCLC patients enrolled, with 23 of the patients being evaluable for efficacy. Thirteen of the evaluable patients received the target dose of 960 mg once daily, of which seven (54%) achieved a partial response at one or more timepoints and six (46%) achieved stable disease, for a disease control rate of 100%.

Among the 34 NSCLC patients enrolled, there were no observed dose-limiting toxicities and no adverse events leading to discontinuation. Twenty-seven of these patients remain on treatment. Of the 34 patients, only nine (26.5%) reported treatment-related adverse events (TRAEs) of grade 1 or 2. Three patients reported grade 3 TRAEs (anemia and diarrhea).

David M. Reese, M.D., executive vice president of Research and Development at Amgen, commented:

These new data reinforce the earlier positive response rate we shared at ASCO in more non-small cell lung cancer patients receiving AMG 510. We remain enthusiastic about the promise of AMG 510 and continue to rapidly advance its development program both as monotherapy and in combination.

Shares of Amgen were last seen down about 3% at $201.74, with a 52-week range of $166.30 to $211.90. The consensus analyst price target is $213.32.

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