Roche seizes chance for Tecentriq combo in first-line lung cancer

Combining Roche’s Tecentriq with its older drug Avastin helped slow progression of advanced lung cancer in first line patients - data which could help the immunotherapy leapfrog its competitors.

The company now plans to file the data from the trial in previously untreated advanced non-squamous non-small cell lung cancer, which it hopes will give it an edge in this huge market.

Roche hopes that Tecentriq could streak ahead of rivals on the back of these results at a time when it  its top three selling drugs - Avastin, rituximab, and Herceptin face competition from biosimilars.

Findings presented at the European Society for Medical Oncology conference on immunology are significant as several big pharma companies producing immunotherapies are targeting the lucrative first-line lung cancer indication, with mixed success.

Merck & Co got its Keytruda (pembrolizumab) approved in first line lung cancer in May, but this was based on a much smaller study than the 1,202 patients enrolled in Roche's trial

More recently, AstraZeneca’s immunotherapy combination of Imfinzi (durvalumab) and tremelimumab also fell short in interim data from a first-line lung cancer trial, although the company hopes the trial will show a benefit in later read-outs.

Commenting on the results on behalf of ESMO, Professor Solange Peters, head of medical oncology at Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, said

“When you look at the 12-month PFS, you double the number of patients who have not progressed from 18% without immunotherapy to 37% when you add the immunotherapy.”

She added: “This is very, very promising. Doubling PFS at one year is something we have not seen with any targeted therapy in unselected patients to date.”

Non-squamous disease accounts for around three quarters of NSCLC cases, so approval in the use covers a wide section of the disease population.

Results from Roche’s pivotal phase 3 Impower150 study showed a combination of Tecentriq (atezolizumab), Avastin (bevacizumab) and carboplatin and paclitaxel chemotherapy reduced risk  of disease worsening or death by 38%, compared with Avastin plus chemotherapy.

Roche’s Genentech unit said a doubling of the 12-month landmark progression-free survival rate was observed with the combination of Tecentriq and Avastin plus chemo, compared to Avastin plus chemotherapy (18%).

The rate of tumour shrinkage (overall response rate, ORR), a secondary endpoint in the study, was higher in people treated with Tecentriq and Avastin plus chemotherapy compared with Avastin plus chemotherapy (64% vs. 48%).

The safety profile of the Tecentriq and Avastin plus chemotherapy combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.

The analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type, ITT-WT) and in a subgroup of people who had a specific biomarker (T-effector “Teff” gene signature expression, Teff-WT).

IMpower150 met its PFS co-primary endpoint per study protocol for both populations assessed. In the Teff-WT population, the combination of Tecentriq and Avastin plus chemotherapy reduced the risk of disease worsening or death by 49 percent compared to Avastin plus chemotherapy.

Overall survival results are due next year.

Sandra Horning, Roche’s chief medical officer and head of global product development, said: “This Tecentriq study is the first positive phase 3 combination trial that showed a cancer immunotherapy reduced the risk of the disease getting worse when used as an initial treatment in a broad group of people with advanced non-squamous NSCLC.”

“The IMpower150 study represents an important advance in lung cancer treatment, and we will submit these results to regulatory authorities around the world to potentially bring a new standard of care to people living with this disease as soon as possible.”

Roche also posted interim data from its recently approved haemophilia drug Hemlibra (emicizumab) dosed every four weeks, saying results were consistent with previous studies of the medicine dosed once a week or every two weeks.