By Deena Beasley
(Reuters) -Gilead Sciences said on Monday a late-stage trial of its antibody-drug conjugate Trodelvy failed to show that it significantly improved survival for previously treated patients with advanced non-small cell lung cancer (NSCLC).
Shares of the California-based drugmaker fell about 8.6% to $79.72 in premarket trading.
The Phase 3 study, aimed at expanding the use of Trodelvy, showed that patients with both squamous and non-squamous NSCLC – the most common type of lung cancer – who were treated with Trodelvy lived longer than those given chemotherapy, Gilead said. However, the difference was not statistically significant, it said.
The trial involved 603 patients with metastatic or advanced NSCLC that had worsened during or after the current standard treatment regimen of platinum-based chemotherapy and a checkpoint inhibitor, such as Merck’s Keytruda.
Gilead said it plans to discuss the second-line lung cancer trial results with regulators and to present the full data at an upcoming medical meeting.
It said the trial showed a more than three-month survival benefit for a sub-group of patients who had not responded to their last prior checkpoint inhibitor treatment and it intends to explore potential pathways to understand the drug’s effect for those patients.
Gilead is also conducting Phase 2 and 3 trials of Trodelvy in combination with Keytruda as an initial treatment for NSCLC patients.
The Phase 3 front-line trial is currently enrolling patients and results will not be available for “a couple of years at least,” Merdad Parsey, Gilead’s chief medical officer, told Reuters.
The latest data “gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” he said.
Parsey said the safety profile for Trodelvy was consistent with prior studies, with the most common adverse events being neutropenia, or low white blood cell counts, and diarrhea.
Trodelvy, which targets a cell surface antigen known as Trop-2 expressed in multiple tumor types, is currently approved by U.S. regulators for patients with two specific types of advanced breast cancer and bladder cancers.
For the indications Trodelvy is already approved for, Gilead’s sales totaled $765 million in the first nine months of last year.
(Reporting by Deena Beasley; Editing by Christopher Cushing)
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