By Josh Nathan-Kazis
New data on a key drug in Amgen’s cancer pipeline sent shares of the company down 3.6% in premarket trading on Monday, though the company said it remained enthusiastic about the promise of the drug.
The data was on a Phase 1 study of AMG 510, a so-called KRAS inhibitor, which is designed to switch off a gene linked to cancer. It is the first in a wave of similar drugs. Amgen’s data showed that 54% of the non-small cell lung cancer patients studied in the trial responded to the drug, but questions remain about the durability of the drug’s effect.
“We and investors had high expectations for this data,” wrote Cantor Fitzgerald analyst Alethia Young in a note out Sunday. Young wrote that the response rate was “fine,” but that she had “hoped to see longer durability.”
The back story. Shares of Amgen (ticker: AMGN) are up 6.7% this year, slightly outperforming the iShares Nasdaq Biotechnology ETF (IBB), which is up 6% over the same period. AMG 510 has been a big part of the company’s story in recent months, with strong data boosting the stock in July despite earnings results that weren’t without flaw.
The Next Frontier in Treating Disease
What’s new. In a presentation at a key cancer conference in Barcelona on Sunday, Amgen announced updated data on its Phase 1 trial of AMG 510, including additional non-small cell lung cancer patients. The company said 13 of the patients received 960 mg of AMG 510 daily, and that 7 of those achieved a partial response.
“These new data reinforce the earlier positive response rate we shared at ASCO in more non-small cell lung cancer patients receiving AMG 510,” David M. Reese, Amgen’s president of research and development, said in a statement. “We remain enthusiastic about the promise of AMG 510 and continue to rapidly advance its development program both as monotherapy and in combination.”
For analysts, though, “durability of response remains our key question,” Young wrote.
Citi Research analyst Mohit Bansal said in a note on Sunday that the drug appears to be “active and safe,” and said that while durability is a question, it could be resolved by giving the drug in combination with other agents.
“Given the benign safety profile, it will likely shine as a combination agent,” Bansal wrote. “Given AMG510 is active by itself, we think even additive effect with other anti-cancer therapies could deepen responses and, potentially, durability.”
Looking forward. Investors remain unconvinced, sending the stock down 3.6% to $200.24 in premarket trading on Monday. Shares of Mirati Therapeutics (MRTX), which is also testing a KRAS inhibitor, were also down 2.6% to $85. S&P 500 futures were up 0.3%.
Write to Josh Nathan-Kazis at email@example.com