Pfizer’s PhIII kidney cancer study for Inlyta flops as investigators flag a dead end on outcomes

Pfizer has lost out on a Phase III bid to revive flagging sales of its VEGF inhibitor Inlyta (axitinib). 

Researchers say their drug, initially approved as a second-line kidney cancer drug 6 years ago, failed to make a favorable impact on patients at high risk of recurring kidney cancer, unable to beat out a placebo for maintaining disease-free rates. The trial was stopped after independent monitors called it on clear evidence of futility.

Mace Rothenberg, Pfizer

That’s not what Pfizer wanted to hear as it looked for new ways to back stop a suffering Sutent franchise, and it was particularly unwelcome after Inlyta revenue slipped in Q4. Late last year Pfizer won an approval to market Sutent for this high-risk category in kidney cancer, even though the expert panel they called on to review the application split their vote, with several members unhappy with the drug’s risk profile.

The pharma giant, though, is pushing ahead with higher hopes for its clinical work on a combination of Inlyta with its PD-L1 checkpoint avelumab — developed by Merck KGaA — though avelumab has had a couple of other setbacks as well. And Sutent will likely be overwhelmed fairly soon by the wave of I/O drugs seeking expanded approval. 

The FDA granted Pfizer’s checkpoint combo a breakthrough designation for renal cell carcinoma last December.

Pfizer, though, hedged its bets on this gamble, so it won’t have to eat the costs. SFJ Pharmaceuticals supervised the work and provided the funding, with this program one of a slate of studies in which it gambles investor cash for pharma partners looking for some creative ways to expand their pipeline work while keeping a lid on R&D costs. SFJ also conducted a trial for Pfizer’s dacomitinib in Asia. That drug is now under FDA review.

“We are disappointed by the outcome of this study as we had hoped the efficacy that INLYTA has demonstrated as a second-line treatment in patients with advanced renal cell carcinoma would carry over to patients with earlier stage disease, where it would delay or prevent disease relapse. That goal was not achieved. We will conduct additional analyses on the data that may provide insight into this result. Studies evaluating INLYTA in combination with immune checkpoint inhibitors for patients with a variety of advanced stage cancers, including RCC, will continue,” said cancer R&D chief Mace Rothenberg.

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