Merck's powerhouse Keytruda whiffs breast cancer trial, delaying hopes for new use

Keytruda
Merck is trialing Keytruda in a range of triple negative breast cancer studies. (Merck)

Right now, Roche’s Tecentriq is the only immuno-oncology drug approved in triple negative breast cancer. And it looks like it’ll stay that way for awhile.

Merck's steamroller Keytruda turned in a rare phase 3 trial miss, failing to extend the lives of previously treated patients with the tough-to-tackle breast cancer form. The company's release late Monday was light on the details, which will roll out at a future medical meeting.

RELATED: Roche's I-O drug Tecentriq picks up key first-in-class breast cancer nod

Webinar

Use Serialization Data to Maximize Performance and Minimize Risks

Wednesday, March 18 | 11am ET / 8am PT

Serialized products generate a wealth of data as they move through the supply chain. What if you could access and analyze this data to gain operational visibility and powerful business insight? It’s time to put your serialization investment to work for you.

That means Keytruda won’t be joining Tecentriq on the list of approved triple negative breast cancer drugs—at least in the short term. But Roy Baynes, Merck senior vice president and head of global clinical development, stressed that the disease gets even more difficult to treat the second and third time around. And that made this second-line trial a particular challenge for Keytruda, or any treatment for that matter.

“Metastatic triple-negative breast cancer is an aggressive and challenging disease to treat, especially after progression on initial standard-of-care treatment,” he said in a statement.

Tecentriq, meanwhile, picked up an FDA green light in March for use in new patients. The OK followed data showing that the checkpoint inhibitor coupled with Celgene chemo drug Abraxane pared down the risk of disease worsening or death by 20% in patients whose tumors express the PD-L1 protein. Roche has that market all to itself for now—and that's something Tecentriq can’t boast in many cancer types, thanks in part to Keytruda’s wide collection of indications.

RELATED: ASCO: Merck's solo Keytruda wins again, but might just leave room for competition

Of course, Merck is looking to bring Keytruda into triple negative breast cancer earlier in treatment, as Baynes noted, and it’s also testing the drug alongside chemo—a tactic that’s yielded stronger results than monotherapy in some tumor types, including non-small cell lung cancer. Three of the drugmaker's ongoing Keytruda studies could underpin FDA applications, including Keynote-522, which is examining Keytruda-plus-chemo in patients before and after surgery, more properly known as the neoadjuvant and adjuvant settings.

Suggested Articles

Several of the industry's top players had a strong performance in the fourth quarter, growing revenues at high single digits. Others? Not so much.

Viatris, the merger of Mylan and Pfizer's Upjohn, has fleshed out its board and C-suite with a raft of Pfizer and Mylan veterans.

An FDA approval of Lilly’s Cyramza combo would pit it against AZ's Tagrisso, which has charted impressive survival gains in EGFR-positive lung cancer.