Roche announced Monday that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS), with the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy as a first-line treatment for people with advanced non-squamous non-small-cell lung cancer (NSCLC) significantly extending survival compared with Avastin plus chemotherapy. The company noted that a survival benefit was observed across key subgroups, including those with varying levels of PD-L1 expression.
In November last year, Roche reported that in the study, the combination of Tecentriq and Avastin plus chemotherapy provided a significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy. Results later detailed at the European Society for Medical Oncology (ESMO) immuno-oncology congress showed that 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.
The IMpower150 study randomised 1202 people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease 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 OS, with the analysis of the former goal only statistically powered to demonstrate a comparison between patients wo received Tecentriq and Avastin plus carboplatin and paclitaxel and those given Avastin plus carboplatin and paclitaxel.
According to Roche, at the latest interim analysis, results found that substituting Avastin with Tecentriq in the combination with chemotherapy did not show a significant OS benefit compared to the combination of Avastin plus chemotherapy. The company added that the study will continue as planned to the final analysis, with data scheduled to be presented at an upcoming medical meeting.
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Sandra Horning, head of global product development, said "we will submit these additional data to global health authorities and hope to bring this potential treatment option to patients as soon as possible." Roche is investigating Tecentriq alone or in combination in eight Phase III lung cancer studies, with three more trials expected to report this year. Last week, the drugmaker announced that results from the Phase III IMpower131 demonstrated that the combination of Tecentriq plus chemotherapy reduced the risk of disease worsening or death compared with chemotherapy alone in the initial treatment of people with advanced squamous NSCLC.
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. The product generated sales of 487 million Swiss francs ($515 million) last year.
Analysts at Baader Helvea said the latest findings complete an "already robust" set of data for Tecentriq as an initial treatment for NSCLC. "We continue to see Roche efficacy more than sufficiently competitive to grant a 43 percent market share in the indication, translating in 4.9 billion [Swiss] francs Tecentriq peak sales and 1.2 billion francs in 2018," Baader's Bruno Bulic remarked, adding "facing biosimilar competition...we see Tecentriq sales coming timely to support Roche's profitability going forward."
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