Roche's Genentech unit announced detailed results from the Phase III IMpower150 study, which the company reported last month met its co-primary endpoint, showing that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy provided a significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small-cell lung cancer (NSCLC). The data are scheduled to be presented Thursday at the European Society for Medical Oncology (ESMO) immuno-oncology congress.
According to the results, patients who received Tecentriq and Avastin plus chemotherapy had a 38 percent reduced risk of their disease worsening or death compared with those who received Avastin plus chemotherapy, with respective median progression-free survival (PFS) of 8.3 months and 6.8 months. Further, a doubling of the 12-month landmark PFS rate was observed with the combination of Tecentriq and Avastin plus chemotherapy, where it was 37 percent, compared to Avastin plus chemotherapy, where it was 18 percent.
Sandra Horning, Roche's head of global product development, said "this…study is the first positive Phase III 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." Horning added "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."
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In the study, 1202 people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease were randomised to receive Tecentriq plus carboplatin and paclitaxel, Tecentriq and Avastin plus carboplatin and paclitaxel or Avastin plus carboplatin and paclitaxel. The trial's co-primary endpoints were PFS and overall survival (OS), with the analysis of the former goal only statistically powered to demonstrate a comparison between patients who received Tecentriq and Avastin plus carboplatin and paclitaxel and those given Avastin plus carboplatin and paclitaxel.
The company reaffirmed that as previously indicated, early results from the co-primary endpoint of OS are "encouraging," with preliminary data showing a 4.8 month benefit in favour of Tecentriq, Avastin and chemotherapy, where OS was 19.2 months, versus Avastin and chemotherapy alone , where OS was 14.4 months. Roche noted that the next OS interim data are anticipated in the first half of 2018. Further results showed that the rate of tumour shrinkage, a secondary endpoint in the study, was higher in people treated with Tecentriq and Avastin plus chemotherapy compared with Avastin plus chemotherapy, with rates of 64 percent and 48 percent, respectively.
According to Roche, as well as being assessed in all patients in the study, the co-primary PFS endpoint was evaluated in a subgroup of people who had a specific biomarker dubbed Teff. Results demonstrated that in this patient 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, with respective median PFS of 11.3 months and 6.8 months.
Commenting on the results, Baader Helvea analyst Bruno Bulic said "we see the IMpower150 outcomes sufficient for Roche to submit a robust data package to the health authorities and very likely obtain a marketing authorisation in the US by mid-2018." Meanwhile, Bernstein's Tim Anderson noted that the study "is one important piece of a complex, still largely incomplete, puzzle," adding "this gives us a snapshot of the data, but not the complete picture." Analysts expect sales of Tecentriq to reach $4.6 billion by 2023.
Tecentriq, a monoclonal antibody designed to bind with the PD-L1 protein, is approved in Europe, the US and more than 50 countries for people with previously treated metastatic NSCLC and for those with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.
For related analysis, see ViewPoints: Merck & Co.'s early-bird data stops Roche from taking flight out of ESMO-IO.
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