Amgen touts two cancer study wins amid second-quarter earnings update

Two cancer drugs succeeded in mid- or late-stage clinical studies, Amgen said Thursday in its second-quarter earnings announcement.

Peter Griffith

“Momentum is building in the pipeline,” Amgen CFO Peter Griffith told Endpoints News, adding the biotech plans to discuss both datasets with regulators, calling a study for the DLL3-targeting drug tarlatamab “potentially registrational.”

In a Phase II small cell lung cancer study, tarlatamab showed a durable response rate that “substantially exceeds what was previously reported in the Phase I study,” the $123 billion drugmaking giant said in its midyear update. But specific data were sparse in Thursday’s release; Amgen said it will present more detailed results at an upcoming medical conference.

The tarlatamab trial enrolled patients who had already failed two prior treatments, and Amgen now plans to start two additional Phase III studies to test giving the drug as an earlier line of therapy in small cell lung cancer.

DLL3 has been a tricky target for the pharma industry, highlighted by AbbVie’s disastrous multibillion-dollar acquisition of Stemcentrx’s Rova-T program. Rova-T also targeted DLL3 and encountered a mix of clinical failures and toxicity problems that derailed its clinical development plans. But Amgen has more hope with tarlatamab, a bispecific T-cell engager that produced promising Phase I results last year, including a median duration of response of 13 months.

Amgen also reported a Phase III success for its KRAS G12C drug, Lumakras, in colorectal cancer. That trial, called CodeBreaK 300, tested Lumakras in combination with the chemotherapy Vectibix against the current standard of care. The study succeeded on its goal of progression-free survival, Amgen said. Again, exact figures were not disclosed.

Lumakras became the first-ever drug to win FDA approval in targeting KRAS, a notoriously hard-to-drug protein that plays a key role in certain types of cancer when mutated. It was initially approved in non-small cell lung cancer. Second-quarter sales came in at $77 million, flat from a year ago. Griffith said treating additional types of cancer, and as an earlier-line therapy, is how sales will grow in the future. The newest readout “makes us optimistic about potential other indications,” he added.

The two readouts led the company’s second-quarter earnings announcement, which included quarterly revenues of $7 billion, up 6% from a year ago.

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