Roche has opted to withdraw its filing in Europe for a dual regimen for renal cell carcinoma based on checkpoint inhibitor Tecentriq and Avastin, on the grounds that the data supporting it isn’t strong enough.
The combination of PD-L1 inhibitor Tecentriq (atezolizumab) and anti-VEGF drug Avastin (bevacizumab) is at the heart of Roche’s immuno-oncology strategy, but it will have to wait a little longer before it can bring it forward for RCC, the most common form of kidney cancer.
Roche was seeking approval for Tecentriq and Avastin as a first-line treatment for advanced or metastatic RCC based on the results of the phase 2 IMmotion151 study, which showed that the duo reduced progression-free survival (PFS) by 26% compared to Pfizer’s Sutent (sunitinib), a standard first-line therapy.
The results, which were unveiled with some fanfare a few months ago, have also been filed with other regulators including the US FDA, but a spokesperson for Roche said that all applications have been withdrawn.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has said that Roche opted to withdraw the application via a letter that said the trial results “are not sufficient to support an extension of indication at this time” and the trial will continue to “the next analysis for overall survival.”
Just when that will occur isn’t clear. As IMmotion151 is an event-driven study, “we are waiting for the data to mature,” said the spokesperson, adding: “we believe that the combination of Tecentriq and Avastin may play a role in the treatment of metastatic RCC [which] remains an area of high unmet medical need.”
It’s not the first regulatory hiccup for Roche’s Tecentriq/Avastin combination. A few weeks back the FDA said it would need more time to review an application for first-line use of the pair in non-small cell lung cancer (NSCLC) based on the IMpower150 study, delaying its verdict by three months. In that trial Tecentriq and Avastin were compared to chemotherapy in non-squamous NSCLC.
CHMP changes its mind on Opdivo/Yervoy
There was better news for RCC patients at the CHMP’s meeting last week on another combination, which has now been recommended for approval by the panel.
Bristol-Myers Squibb’s combination of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) had been turned down by the CHMP earlier this year on the grounds that adding low-dose Yervoy seemed to provide little additional benefit over Opdivo alone but added to its side-effect burden. The US FDA approved the new use for the drugs in April.
After a re-examination of the CheckMate-214 trial comparing the combination to Sutent, which was the basis of the application, the CHMP now feels there is a “clinically important increase in patients’ survival” as well as acceptable side effects, opening the door to an EMA approval in the coming weeks.
It’s good news for BMS, which has been trying to defend its sales projections for Opdivo in light of a series of positive trial read-outs for rival PD-1 inhibitor Keytruda (pembrolizumab) from Merck & Co/MSD, including impressive survival data in combination with Pfizer’s Inlyta (axitinib) in the phase 3 KEYNOTE-426 trial reported at this year’s ESMO meeting.
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