Pfizer strikes out on Inlyta expansion bid with postsurgery kidney cancer failure

Investigators stopped an Inlyta study in recurrent renal cell carcinoma due to futility. (Pixabay)

Pfizer has been looking to expand kidney cancer drug Inlyta's use to renal cell carcinoma (RCC) patients at a high risk of disease recurrence following surgery—but on that front, it's fallen short.

The drug, already approved solo to treat advanced RCC for patients who have failed on one other treatment, didn't top placebo at improving disease-free survival, the New York drugmaker reported

That finding prompted an independent data monitoring committee to call for a stop of the trial.

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"We will conduct additional analyses on the data that may provide insight into this result," Pfizer oncology R&D chief Mace Rothenberg, M.D., said in a statement. 

While it's a setback for Pfizer's oncology pipeline, the company isn't taking the entire hit. SFJ Pharmaceuticals funded the test and provided clinical supervision, according to a Pfizer press release. 

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Meanwhile, Pfizer is still pressing ahead with its combo of Inlyta and Bavencio—shared with Merck KGaA—in first-line advanced RCC. In December, the pairing won the FDA's Breakthrough Therapy Designation based on an initial look at phase 1b results. 

On the company's fourth-quarter conference call, R&D chief Mikael Dolsten said data so far have been "really impressive," adding that in his opinion, they're "absolutely" the "best seen this far." 

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A phase 3 trial readout will come in the next 12 months, Dolsten said on the call. Pfizer and Merck & Co. are also testing a combo of Inlyta and Keytruda as an adjuvant treatment in RCC, according to Pfizer's online pipeline. 

But the new trial failure comes shortly after Inlyta's sales fell 15% in 2017 to $339 million, Pfizer reported. 

Inlyta is intended to be a follow-up to Sutent, a standard-of-care therapy facing new pressure from Bristol-Myers Squibb and Roche cancer meds. Sutent's sales slipped 1% in 2017 to $1.08 billion.