Amgen Plans Pivotal Lung Cancer Trial For Its Pipeline Star

In Clinical Trials by Barbara Jacoby

Source: Andrew Dunn, BiotechDive

From: pharmavoice.com

Amgen stole the show at this year’s annual meeting of the American Society of Clinical Oncology with promising early data from a cancer drug designed to target KRAS mutations, an elusive target that’s frustrated decades of research efforts.
Now, the biotech plans to soon advance the drug into a Phase 2 study in lung cancer that could clear a path for an application to the Food and Drug Administration, Amgen R&D head David Reese said on a second quarter earnings call Tuesday.
Further driving enthusiasm for the closely watched drug was Amgen’s disclosure that it’s observed tumor responses in colorectal and appendiceal cancer patients. At ASCO, the company’s initial findings only showed a treatment effect in study participants with lung cancer. Amgen will give a further update on the drug, called AMG 510, at the 2019 World Conference on Lung Cancer in September.

Dive Insight:
Rarely do drugs with data from only a few dozen patients get as much attention as Amgen’s KRAS inhibitor has, a result of both the mutation’s prevalence and past resistance to efforts at targeting it.

At ASCO, Amgen’s initial data showed five of 10 lung cancer patients had a response to treatment, a finding that suggests the biotech has hit on a credible treatment approach.

Since then, the oncology community’s response has been “simply overwhelming,” Amgen’s Reese said on the Tuesday earnings call.

Being the center of attention in oncology is an unfamiliar spot for Amgen, but is also indicative of the biotech’s distinctly different future. Tuesday’s earnings showed a new Amgen, SVB Leerink analyst Geoffrey Porges wrote, one characterized by “flat revenue, a promising pipeline and nervous investors.”

Quarterly revenue declined 3% from a year ago, as slowing sales from older drugs facing market competition outweighed contributions from newer launches.

Still, Amgen remains optimistic its pipeline can bring new growth, headlined now by AMG 510 as a pipeline star, Cantor Fitzgerald analyst Alethia Young wrote Wednesday.

The update on a registrational trial and disclosure of new tumor response will only intensify interest in the drug, Wall Street analysts stated.

That study will test the highest dose of 960 mg in AMG 510’s lead indication of lung cancer. And while Amgen didn’t provide specific data on the new responses observed in colorectal and and appendiceal cancer, Amgen’s R&D head did highlight combination studies in the drug’s future.

“In terms of colorectal cancer, obviously combinations will be of great interest going forward, potentially both with immunotherapeutic agents and additional targeted therapies,” Reese said. “And as that program moves forward, we’ll provide additional guidance a little later in the year and early into next year.”

The planned September update in lung cancer, meanwhile, could go some ways to validating oncologists’ optimism about the KRAS inhibitor.

As one leading oncologist told BioPharma Dive at ASCO, the 50% response rate in lung cancer is exciting, but limited by the small number of patients.

“Five out of 10 is a pretty small number,” said Roy Herbst, chief of medical oncology at the Yale Cancer Center. “If you want to say something really has a 50% response rate, you should have 30 or 40 patients to have some precision behind that measurement.”