Merck & Co.'s Immuno-Oncology Star Racks Up Two New Bladder Cancer Approvals

Published: May 19, 2017

Merck & Co.'s Immuno-Oncology Star Racks Up Two New Bladder Cancer Approvals May 19, 2017
By Mark Terry, Breaking News Staff

Merck & Co ’s Keytruda continues to expand for new indications. The U.S. Food and Drug Administration (FDA) approved it for two new indications.

For first-line treatment, Keytruda was approved for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. Urothelial carcinoma is a type of bladder cancer. This was approved under an accelerated approval based on tumor response rate and response duration. The approval is contingent upon verification and description of clinical benefit in confirmatory clinical trials.

For second-line treatment, Keytruda was approved in locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Keytruda (pembrolizumab) is an anti-PD-1 immuno-oncology therapy. It stimulates the body’s immune system to help detect and fight tumor cells, by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which activates the body’s T-cells. Keytruda is involved in almost 500 clinical trials in more than 30 cancers and treatment settings.

“Keytruda is now available for use as a first-line treatment option for patients with advanced urothelial bladder cancer who are not eligible for the standard of care, cisplatin-based chemotherapy,” said Dean Bajorin, study investigator and medical oncologist at Memorial Sloan-Kettering Cancer Center, in a statement. “With the second-line indication, Keytruda also provides a new option for patients with advanced urothelial bladder cancer—and is the only anti-PD-1 therapy to show an overall survival benefit versus chemotherapy in a Phase III study.”

Merck is currently trading for $63.70.

Analysts are projecting company sales for the current fiscal quarter will hit $9.68 billion. Four analysts had estimates that ranged from $9.5 billion to $9.8 billion. In the same quarter last year, Merck announced $9.84 billion in sales. The next quarterly earnings report is July 28.

Sanford Bernstein recently reissued a “market perform” rating on February 24. Leerink also reissued “market perform” on March 20. Vetr upgraded from a “hold” to a “buy” rating with a price target of $69.31 on March 8.

Merck is also presenting an abstract at the upcoming ASCO conference on Keytruda for advanced nonsquamous non-small cell lung cancer (NSCLC), which updates its KEYNOTE-021 clinical trial. In a recent note to investors, Tim Anderson, an analyst with Bernstein, noted that the European Medicines Agency (EMA) agreed to accept Merck’s combination treatment for review. The FDA had approved it earlier this month as first-line treatment in lung cancer, but “the bar to filing/approval is typically much higher” in the European Union.

There was skepticism about overall survival (OS), but Anderson wrote, “There have been concerns that chemotherapy might adversely impact the immune system, thereby rendering immune-activating by a PDx ineffective if given in combination, and negating any OS benefit.”

Carly Helfand, writing for FiercePharma, said, “It’s been a good couple of weeks for Merck—and, by extension, Roche , which is testing a chemo combo of its own. The FDA green-lighted the Keytruda-chemo one-two punch last Wednesday, making ‘the first true endorsement of the general “chemo combo” approach,” Anderson wrote at the time. Now the pressure’s on Bristol-Myers Squibb and AstraZeneca , which have gone in another direction with their combos. The drugmakers have matched their checkpoint inhibitors up with CTLA-4 meds, and it’s not yet clear if those will succeed—and if they do, how they will stack up against the Merck-Roche approach.”

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