Roche has added another FDA nod to its Tecentriq arsenal as it tries to challenge Keytruda’s lead in non-small cell lung cancer (NSCLC).
Tuesday, the FDA approved Tecentriq in combination with Celgene’s chemotherapy Abraxane and carboplatin for the treatment of newly diagnosed nonsquamous NSCLC with no EGFR or ALK mutations.
The approval comes on the strength of the IMpower130 study, which showed the Tecentriq combo could extend patients’ lives by a median 18.6 months, significantly longer than the 13.9 months those on chemo alone experienced.
This is not Tecentriq’s first go-ahead in front-line NSCLC—and arguably not even the most important one—but it does show Tecentriq can work with chemo. A year ago, the FDA approved a pairing of Tecentriq, Avastin and chemo in that exact same setting after the phase 3 IMpower150 study showed the cocktail could help people live a median 19.2 months.
At last year’s European Society for Medical Oncology meeting, Alan Sandler, M.D., Roche’s global head of lung and head and neck cancer, argued that the Avastin-containing regimen offered a survival benefit in patients with liver metastases, which IMpower130 didn’t produce.
It would be nice for Roche if Tecentriq-Avastin-chemo could become the treatment of choice for the niche liver metastases population—which makes up about 30% to 35% of the lung cancer population, according to Sandler—because in terms of clinical results, the newly approved Tecentriq-chemo combo is no match for Merck & Co.’s Keytruda-chemo pairing.
Last April, Merck showed Keytruda in tandem with Eli Lilly’s chemotherapy Alimta and platinum chemo cut the risk of death by half in first-line nonsquamous NSCLC. In an update of that Keynote-189 trial at this year’s American Society of Clinical Oncology meeting, Merck showed patients on the Keytruda regimen lived a median 22 months compared with 10.7 months for those on chemo alone.
As the leader in NSCLC, Keytruda also boasts approval as a single agent for previously untreated NSCLC patients whose tumors express PD-L1. Roche recently also turned up solo Tecentriq data, showing the drug could extend lives by an additional 7.1 months over chemo, posting a benefit of 20.2 months versus chemo's 13.1 months in patients with high levels of PD-L1.
As Roche prepares applications for the use to regulators, SVB Leerink analyst Daina Graybosch has contended it would be hard for Roche to challenge “[t]he lead and loyalty for Keytruda among oncologists treating NSCLC.” Nevertheless, she sees potential for combinations on top of Tecentriq now that it has a monotherapy trial win.
Besides Tecentriq, other PD-1/L1 players are also eyeing additional shares of the lucrative NSCLC market. Bristol-Myers Squibb has shown that Opdivo plus CTLA4 inhibitor Yervoy and chemo have together beaten out chemo alone at extending survival in first-line NSCLC in the CheckMate-9LA study. AstraZeneca, for its own regimen of dual immuno-oncology agents plus chemo, announced that an Imfinzi-tremelimumab-chemo trio outperformed solo chemo at keeping patients’ cancer from progressing in the Poseidon trial.