Pfizer’s old dog Sutent has shown it has one more trick to perform as a renal cancer treatment before being passed up by the new breed of immuno-oncology drugs.
Despite misgivings by an FDA advisory panel, the FDA Thursday approved Sutent to treat adult patients who are at a high risk of seeing their kidney cancer return after they have had a kidney removed. It is the first adjuvant treatment approved for renal cell carcinoma, the FDA said.
The decision was based on a study in which 59.3% of patients treated with Sutent had not had a recurrence or died after five years compared with 51.3% of patients who were given a placebo.
The agency’s Oncologic Drug Advisory Committee turned in a tie vote of 6-6 when it voted on the indication in September, with members put off by data that showed Sutent patients were three times as likely to suffer serious side effects. More than 60% of the patients in the Sutent arm reported side effects of grade 3 or above, compared with 21% of placebo patients.
“Sutent has been a standard of care for the treatment of advanced RCC since it was approved more than a decade ago, and is now the first approved adjuvant treatment option for certain patients at high risk of recurrent RCC—the most common type of kidney cancer,” Pfizer said in a statement. “The current treatment approach for RCC patients is surgery followed by observation, which is suboptimal for patients at high risk of recurrence.”
The approval should jump-start Sutent sales, which have lagged of late. Barely a blockbuster at this point, its 2016 revenues were down slightly at $1.09 billion, compared with $1.12 billion in 2015. Pfizer has a follow-up—Inlyta—that it’s also testing in post-surgery patients, alongside Merck’s Keytruda and Pfizer’s own Xalkori.
Sutent has been a market leader in kidney cancer since its initial approval in 2006, but analysts think its days are numbered in the top spot in the face of an onslaught of immono-oncology drugs, particularly given recent results of a combo of Bristol-Myers Squibb’s I-O drugs Opdivo with Yervoy against Sutent.
In the head-to-head, the combo the Opdivo-Yervoy pairing delivered a 37% reduction in the risk of death compared with Sutent in intermediate- and poor-risk patients. In all the trial patients, the reduction in death risk amounted to 32%. In both groups, the median overall survival hadn't yet been reached for the combo arm. The Checkmate-214 trial was stopped after an interim analysis, when a monitoring committee decided the Opdivo-Yervoy combo was too effective to restrict only to the control arm in the study.
When the data was released, Credit Suisse analyst Vamil Divan noted the first-line success puts the company once again ahead of its rivals. Opdivo is already the only PD-1/L1 drug approved in renal cell carcinoma, with a second-line nod in 2015. A potential launch in kidney cancer for the combo next year “would keep Bristol-Myers well ahead of competitors from Roche, Pfizer and Merck,” with their launches in that field estimated for 2019 for the first two and 2021 for Merck, Divan said.