Farmas USA

MRK, INCY, BMY,  PFZ

Incyte wipes out late-phase epacadostat program after pivotal failure of Keytruda combination

The six other pivotal studies are halting recruitment altogether and giving already-enrolled patients the option to switch to different treatments. Those trials include another four testing epacadostat with Keytruda in head and neck cancer, renal cell carcinoma and urothelial cancer. And two from Incyte’s collaboration with Bristol-Myers Squibb that are testing the IDO drug and Opdivo in patients with head and neck cancer or NSCLC.

News of the decision to stop enrollment in the epacadostat-Opdivo trials comes shortly after Bristol-Myers culled its own late-phase IDO activities. The Big Pharma was set to assess its in-house IDO drug and Opdivo in head and neck cancer and NSCLC—the same indications as the epacadostat studies—but backed out after learning of the failure of Incyte’s pivotal Keytruda trial.

https://www.fiercebiotech.com/biotech/incyte-wipes-out-late-phase-epacadostat-program-after-pivotal-failure-keytruda-combination

IDO rout: Pivotal trials with Bristol-Myers, Merck and AstraZeneca dumped in wake of Incyte’s PhIII implosion

$BMY became the third player forced to retrench in that immuno-oncology field, dropping three late-stage studies of a rival drug it bagged in a $1.25 billion buyout

https://endpts.com/bristol-myers-dumps-late-stage-ido-studies-in-wake-of-incytes-pivotal-implosion-in-yet-another-setback/

 

MRK

Merck Looks to Snag Another FDA Approval for Keytruda in Lung Cancer

Merck appears to be on the way to securing an additional approval for Keytruda, its blockbuster checkpoint inhibitor. The company is seeking new regulatory approval for Keytruda, an anti-PD-1 therapy, in combination with Eli Lilly’s Alimta and platinum chemotherapy as a first-line lung cancer treatment.

If approved by the U.S. Food and Drug Administration (FDA), the supplemental Biologics License Application would make the combination treatment a first-line choice for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). After granting Keytruda Priority Review status, the FDA set a PDUFA date of Sept. 23, 2018.

The latest quest for a new approval for Keytruda is based on results from the Phase III Keynote-189 clinical trial, announced earlier this month. Data from the Phase III trial showed that the addition of Keytruda, Alimta and platinum chemotherapy significantly improved overall survival (OS) in the NSCLC patients and reduced the risk of death by half when compared with chemotherapy alone. An OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, Merck said at the time the Phase III results were released.

Not only is Merck seeking regulatory approval for the additional indication of Keytruda in the United States, the company has also submitted the data for review in Europe and Japan

Keytruda also snagged another significant clinical milestone this month for NSCLC. Following an interim review of data in the KEYNOTE-042 trial, the anti-PD-1 therapy hit its endpoints as a first-line monotherapy.

https://www.biospace.com/article/merck-looks-to-snag-another-fda-approval-for-keytruda-in-lung-cancer/