The pharma world is eagerly watching as Amgen moves its KRAS inhibitor toward a regulatory decision, and they now have a name for the much-anticipated new drug: Lumakras.
Amgen listed off a laundry list of clinical trials and regulatory milestones, including the provisional approval for the name Lumakras, while reporting first-quarter earnings April 27. Top on that list, of course, was the FDA’s February decision to grant the therapy priority review, which sets the PDUFA date four months early to Aug. 16. The drug is also being reviewed under the FDA’s Real-Time Oncology Review pilot program, which could speed up a decision even more.
Amgen is hoping Lumakras, formerly just sotorasib, will become a new treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) as a second-line therapy. About 14% of NSCLC patients have this mutation, which adds up to around 14,000 new cases in the U.S. each year.
KRAS was once thought to be an undruggable target in cancer. Amgen is first in line to get a new therapy through the regulatory process, but other companies, most notably Mirati Therapeutics, are on the company’s heels.
Lumakras has now been submitted to regulatory agencies in the EU, Switzerland, U.K., Canada, Brazil and Australia, and the company said a filing would be completed in Japan the same day.
“Our team is ready to launch sotorasib or Lumakras upon approval, and we are excited to establish it as a foundational therapy for patients with advanced lung cancer,” said Murdo Gordon, Amgen’s executive vice president of global commercial operations, during the earnings call.
In an early morning release issued April 28, Amgen also said an agreement had been reached with the FDA to conduct a post-marketing study of a lower dose of Lumakras. The company will now fit a new cohort into the ongoing clinical development program comparing a 960 mg dose with 240 mg. This post-marketing requirement will not impact the priority review timeline, Amgen noted. Enrolment in this study is expected to begin soon.
Amgen provided an update on the expansive clinical program for Lumakras during the earnings call. Enrollment has been completed in a phase 3 trial called CodeBreaK 200 comparing the therapy to the chemotherapy docetaxel in patients with KRAS G12C-mutated advanced NSCLC. The company tweaked the late-stage study following the results from an earlier phase 2 trial and guidance from the FDA to reduce the sample size, which will help gauge the primary goal of progression-free survival.
Data from a phase 2 trial testing Lumakras as a single therapy for patients with NSCLC will be presented at upcoming medical conferences this quarter. Amgen is looking to extend patients’ overall survival and is examining possible biomarkers of resistance in that study.
Mature data from a phase 2 trial for patients with KRAS G12C-mutated advanced colorectal cancer who received just Lumakras are expected in the second quarter as well. The company plans to publish data by the end of the year.
A midstage study for patients with KRAS G12C-mutated solid tumors other than NSCLC and colon cancer has finished enrollment, with a readout landing in the first half of 2022.
Finally, Amgen has a handful of phase 1 studies that are just getting rolling. Lumakras is being investigated in more than 10 combinations, including with Genentech’s Avastin in patients with advanced colorectal cancer. Early data from these programs are expected for presentation sometime in the second half of the year.