Bristol Myers, Exelixis get in FDA fast lane for Opdivo-Cabometyx combo in kidney cancer

Kidney
Bristol Myers Squibb and partner Exelixis won FDA priority review for their application of Opdivo and Cabometyx in kidney cancer. (jlcampbell104/CC BY 2.0)

Fresh off new data showing their Opdivo-plus-Cabometyx combo can help kidney cancer patients live longer, Bristol Myers Squibb and Exelixis are getting VIP treatment from the FDA.

The agency granted the combo priority review for potential use in patients with advanced renal cell carcinoma, the two companies said Monday. By Feb. 20, BMS and Exelixis will know whether they get a chance to go after Merck and Pfizer’s cocktail of Keytruda and Inlyta.

Both combinations marry a PD-1 inhibitor with a tyrosine kinase inhibitor (TKI), and data from their respective trials tell two very similar efficacy stories.

In CheckMate 9ER, Opdivo and Cabometyx cut the risk of death by 40% compared with Pfizer’s Sutent after a median follow-up of 18 months, according to data presented a month ago at the European Society of Medical Oncology (ESMO) virtual meeting.

RELATED: ESMO: Bristol Myers preps 2nd kidney cancer combo nod as Opdivo-Cabometyx duo slashes death risk 40%

As for Keytruda and Inlyta, the two drugs posted a 41% reduction in death risk over Sutent after 17 months of follow-up in the Keynote-426 trial.

Even the duration of the responses was very similar, at 20.2 months for Opdivo-Cabometyx and 20.9 months for Keytruda-Inlyta at their respective follow-up times.

So, the competition could eventually come down to commercial execution, SVB Leerink analyst Daina Graybosch recently said after Opdivo’s ESMO presentation. That could give Merck an upper hand, given Keytruda has a firm hold in the checkpoint inhibitor realm.

But as far as the TKI fight goes, Exelixis’ Cabometyx, approved as a monotherapy in previously untreated kidney cancer, seems to hold an advantage over Pfizer’s solo Inlyta, which is only allowed in the second-line setting.

RELATED: How will BMS' new Opdivo-Cabometyx kidney cancer combo fare against Keytruda? It may come down to marketing: analyst

BMS also has its wholly owned dual-immunotherapy regimen, a combination of Opdivo and CTLA-4 agent Yervoy, which has been marketed since April 2018 in kidney cancer and has longer-term survival data. But that pairing is approved specifically for intermediate- and high-risk patients, while both Keytruda-Inlyta and Opdivo-Cabometyx have delivered benefits for patients regardless of their disease risk profile.

Right now, Graybosch expects doctors to continue to prefer BMS’ dual-immunotherapy regimen, “especially for patients with slower growing, smaller tumors.” As for the two combos of PD-1 and TKI, it could be anybody’s game, as physicians will choose their favorite regimen, she said.