BMS' Opdivo gets a jump on Keytruda with another early FDA approval

Ready for the lung cancer showdown between Merck & Co.'s ($MRK) Keytruda and Bristol-Myers Squibb's ($BMY) Opdivo? It's here, and way ahead of schedule.

Merck scored FDA approval for Keytruda in lung cancer, right on time in early October, giving the drug a few months to gain ground before Opdivo's expanded lung cancer nod was due. But last week, Opdivo won that new lung cancer indication, pitting the two drugs against each other in squamous and non-squamous non-small cell lung cancer.

As the two applications were making their way through the FDA, analysts were slicing and dicing numbers on disease populations and predicting the labeling language that would define each med's target in lung cancer. Because of the way their individual clinical trials were designed, the thinking was that Keytruda's NSCLC nod would be limited to second-line patients testing positive for PD-L1, and Opdivo's wouldn't.

Those predictions came true, with Keytruda's label sticking to the PD-L1 population, and Opdivo's indication, also in previously treated patients, free of PD-L1 limits. Bigger patient populations mean potential sales are bigger, too--and the FDA's official word gives Bristol-Myers more firepower as it guns for first place in the hot immunotherapy field.

The FDA did note the importance of the PD-L1 biomarker in its release about the new Opdivo approval, as Bernstein analyst Tim Anderson wrote in a Friday investor note. Richard Pazdur, who heads up the FDA's Office of Hematology and Oncology Products, noted that Opdivo delivered an "overall survival benefit in certain non-small cell lung cancer patients," but said "it appears that higher expression of PD-L1 in a patient's tumor predicts those most likely to benefit."

The follow-up questions now are, a., whether influential drug compendia follow the FDA's lead in limiting treatment recommendations for Keytruda and not for Opdivo, and b., whether the biomarker distinction between the two meds disappears when treating newly diagnosed patients.

Anderson figures there's a chance that the compendia could recommend Keytruda use in all patients, regardless of PD-L1 status; those decisions will probably come early next month, he says. As for the first-line versus second-line question, Anderson says both companies' trials are focused specifically on previously untreated patients testing positive for PD-L1.

Along with the Opdivo approval, the FDA cleared a PD-L1 companion diagnostic from Dako.

Opdivo's latest nod--in the non-squamous form of NSCLC--follows in the footsteps of its first lung cancer approval, in the squamous disease type. That FDA green light came in February, several months ahead of its PDUFA date. The agency cited Opdivo's ability to prolong patients' lives as a reason for that early decision.

However the Keytruda-vs.-Opdivo battle shapes up, the two meds could soon have another rival: Roche's ($RHHBY) atezolizumab, which targets PD-L1, rather than PD-1 as the other two do. Though the Swiss drugmaker's entrant carries a $2 billion sales estimate right now--compared with $8.8 billion by 2020 for Opdivo, and $5.5 billion for Keytruda--Roche thinks that PD-L1 target, its data in a broad range of cancers, plus some combination-therapy studies, could give atezolizumab a better shot than analysts realize.

October 12, 2015 | By Tracy Staton


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