Amgen May Have the Next Blockbuster Cancer Drug

(Bloomberg) -- Shares of Amgen Inc. jumped as much as 6.1% on Monday, the most intraday in more than two years, after the company said it saw early signs of activity in a study of 35 patients for an experimental drug targeting one of the most commonly mutated genes in cancer. A small-cap peer, Mirati Therapeutics Inc. rallied as much as 43% to a record. Analysts say Amgen’s medicine has the potential to be the next cancer “blockbuster.”

Out of 10 lung cancer patients getting Amgen’s AMG 510 in the early-stage study, five went into partial remission while another four saw their disease stabilize. One patient’s response deepened to a complete remission four months after treatment, following a data cutoff, the company said in a statement.

A 90% disease control rate “is quite notable for a Phase 1 trial where patients get low and often ineffective doses of a drug,” said Elliott Levy, Amgen’s head of global development, before the results were presented at the American Society of Clinical Oncology meeting in Chicago.

AMG 510 targets a specific mutation -- KRAS G12c -- that accounts for about 13% of non-small cell lung cancers and 3% to 5% of colorectal cancers. Getting a drug to work on KRAS mutations has been a target of research for decades, making it what Levy calls “the white whale of drug discovery.”

Amgen’s results in colon cancer were less robust with no patients going into remission; 13 of the 18 patients showed signs of their disease stabilizing. Levy said only one of the six patients who got the highest dose of AMG 510 had colorectal cancer. It’s too early to tell whether AMG 510 has different levels of activity in different tumor types or is “tumor agnostic,” Levy said.

Two patients had serious drug-related toxicities, but were able to continue treatment. Nine patients in the study discontinued treatment because their disease progressed.

GlaxoSmithKline Plc and Mirati Therapeutics Inc are also developing their own medicines for KRAS mutations. Jefferies analyst Maury Raycroft previously said that shares of Mirati could move as much as 15% if Amgen’s dose response and response rates exceeded 40%. JPMorgan, options had indicated as much as a 30% move.

While data are still early, that’s not stopping analysts from saying Amgen’s drug could be a“blockbuster” if the results hold. Street estimates might have to start putting more than $1 billion into estimates, Jefferies analyst Michael Yee wrote. Mizuho analyst Salim Syed says annual sales could peak at $2 billion.

The results are “amazing, even if early,” Bloomberg Intelligence analyst Asthika Goonewardene said.

To contact the reporter on this story: Cristin Flanagan in New York at cflanagan1@bloomberg.net

To contact the editors responsible for this story: Jeremy R. Cooke at jcooke8@bloomberg.net, ;Catherine Larkin at clarkin4@bloomberg.net, Will Daley

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