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Amgen's KRAS Inhibitor Shows Response in Larger NSCLC Group

Zacks Equity Research

Amgen, Inc.’s AMGN novel investigational KRAS inhibitor for solid tumor, AMG 510, showed anti-tumor activity with no dose-limiting toxicities in a larger group of lung cancer patients.

Amgen presented new data from a phase I study evaluating AMG 510 in patients with heavily pretreated KRAS G12C-mutated solid tumors at IASLC 2019 World Conference on Lung Cancer (WCLC).

Amgen shares have risen 6.7% this year so far compared with 2.4% decrease registered by the industry during this period.



In June, Amgen presented encouraging early clinical data on AMG-510 at the annual meeting of the American Society of Clinical Oncology (ASCO). In the phase I study, AMG 510, when given as a monotherapy, showed encouraging anti-tumor activity in patients with locally-advanced or metastatic KRASG12C mutant solid tumors like non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

The follow-up data presented at WCLC was from a larger group of NSCLC patients. The data showed that 54% of the 13 evaluable NSCLC patients, given a high dose of 960 mg once daily, experienced a partial response. Also, 46% of the patients achieved stable disease for a disease control rate of 100% at the target dose.

We remind investors that in July, along with the second-quarter results, Amgen said that AMG-510 showed responses in patients with colorectal and appendiceal cancer. Back then, Amgen had said that it is enrolling patients in a NSCLC cohort in combination with a PD-1 inhibitor. It plans to initiate a registration enabling phase II study soon.

KRAS gene has been a target of active exploration in cancer research and is particularly common in solid tumors. Amgen believes that AMG 510 has the potential to be developed into a successful targeted therapy to treat patients with the KRASG12C mutation due to its high selectivity for this mutation.

AMG510 enjoys orphan drugs status from the FDA for KRASG12C-positive NSCLC and colorectal cancers.

Another company, Mirati Therapeutics Inc MRTX also has a candidate, MRTX849, which targets the KRAS G12C mutation.

Amgen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some other top-ranked biotech stocks include Alexion ALXN and Biogen BIIB. Both carry a Zacks Rank #2.

Shares of Alexion have risen 6.6% this year so far. Earnings estimates for 2019 and 2020 have risen 4.7% and 2.3%, respectively over the past 60 days.

Earnings estimates for Biogen for 2019 and 2020 have risen 9.1% and 3.6%, respectively over the past 60 days.

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