Roche eyes September FDA verdict for triple NSCLC therapy

The FDA has started a six-month review of Roche’s Tecentriq, Avastin and chemotherapy in first-line non-small cell lung cancer, setting up a possible approval by 5 September.

The triple therapy is an important catch-up play for Roche as it tries to build a market for new immuno-oncology drug Tecentriq (atezolizumab) and – crucially – stake a claim for the big first-line NSCLC category that is currently dominated by Merck & Co’s rival drug Keytruda (pembrolizumab).

The submission is based on the IMpower150 study, which combined Tecentriq with Avastin (bevacizumab) and the standard first-line NSCLC chemotherapy regimen paclitaxel/carboplatin and doubled the 12-month progression-free survival (PFS) rate compared to Avastin plus chemotherapy alone.

The trial is hugely important to Roche not only as it could help kick-start sales of Tecentriq, which missed its sales expectations in the first quarter of the year in its current indications of second-line NSCLC and bladder cancer, but also breathe new life into Avastin. The latter remains one of the company’s top-three products but is facing the threat of biosimilar competition in the big US market from next year.

Amgen and Allergan’s Mvasi biosimilar was cleared by the FDA last September, while Boehringer Ingelheim, Samsung Bioepis, Pfizer and Biocon/Mylan also have biosimilars in late-stage development . In Europe Roche is claiming patent protection for Avastin until 2022. Roche is pairing Tecentriq and Avastin in multiple cancer indications, including renal cell carcinoma

Approval by the FDA would set up an intriguing marketing tussle between Roche and Merck, which has made a lot of headway in first-line NSCLC thanks to strong data for Keytruda in combination with chemotherapy.  Adding Avastin into the treatment mix hikes the cost of course.

Meanwhile, Roche reported interim data from the IMpower131 trial of Tecentriq plus chemotherapy in first-line squamous NSCLC in March, but while the initial read-out was positive for PFS, it missed the mark on the overall survival (OS) measure.

Roche has the chance to be first to market with a specific label claim for squamous NSCLC, and meanwhile is also carrying out two studies of Tecentriq or placebo on top of carboplatin and Celgene’s Abraxane (nab-paclitaxel) and Eli Lilly’s Alimta (pemetrexed) in first-line non-squamous NSCLC – IMpower130 and IMpower132 respectively, with results due in the coming months.

There’s no guarantee either Merck or Roche will have it their own way of course. A slew of other drugs and combinations are also aiming to stake a claim to the first-line NSCLC sector, including AstraZeneca with its Imfinzi (durvalumab) and tremelimumab combo, despite mixed results thus far, and Bristol-Myers Squibb’s pairing of Opdivo (nivolumab) and Yervoy (ipilimumab).

“Our phase III results showed Tecentriq in combination with Avastin, paclitaxel and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer,” said Sandra Horning, Roche’s chief medical officer.

“We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible.”