By Elias Schisgall
Merck & Co. and Gilead Sciences are discontinuing a Phase 3 study of a lung cancer treatment but said they saw positive data from other Phase 3 studies in a jointly-developed HIV treatment.
The two pharmaceutical companies said they discontinued a Phase 3 study of Gilead's Trodelvy in combination with Merck's Keytruda in patients with untreated metastatic non-small cell lung cancer.
The decision was based on a recommendation from an external Data Monitoring Committee which reviewed the analyses of progression-free survival and overall survival from the trial data, the companies said. The data did show a numerical improvement in progression-free survival, but not at the level of statistical significance, and a statistically significant improvement in overall survival is unlikely.
In two separate Phase 3 studies, the companies said a combination of islatravir and lenacapavir was not statistically inferior to the drug Biktarvy or standard-of-care treatments in patients with HIV. The two investigational treatments were given together as a once-weekly oral tablet.
Gilead and Merck said they plan to file data from the studies with global regulatory authorities.
"By advancing this investigational novel once-weekly oral regimen of islatravir and lenacapavir, we aim to bring forward a new long-acting oral option that, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV," Merck Research Laboratories Chief Medical Officer Eliav Barr said.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
06-08-26 1716ET
