Merck & Co. announced Sunday at the American Society of Clinical Oncology (ASCO) annual meeting that its anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy reduced the risk of death by a significant 36 percent compared to chemotherapy alone as a first-line treatment for patients with metastatic squamous non-small-cell lung cancer (NSCLC). Further findings from the Phase III KEYNOTE-407 study showed that the addition of Keytruda to chemotherapy also significantly improved progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half.
Meanwhile, Roche reported that in the Phase III IMpower131 study, the combination of Tecentriq (atezolizumab) and chemotherapy reduced the risk of disease worsening or death by 29 percent compared with chemotherapy alone in the first-line treatment of patients with advanced squamous NSCLC. However, the Swiss drugmaker indicated that a significant overall survival (OS) benefit was not observed at the interim analysis, and the study will continue as planned.
In KEYNOTE-407, 559 patients with metastatic squamous NSCLC who had not previously received systemic therapy for advanced disease were randomly assigned to treatment with Keytruda in combination with chemotherapy, consisting of carboplatin-paclitaxel or Celgene's Abraxane (nab-paclitaxel), or chemotherapy alone. The co-primary endpoints of the study were PFS and OS, while secondary goals included objective response rate (ORR) and duration of response.
Results demonstrated that the median OS was 15.9 months in the combination arm, versus 11.3 months for chemotherapy alone, while the median PFS times in these groups were 6.4 months and 4.8 months, respectively. Regarding response, the ORR in the combination group was 57.9 percent, versus 38.4 percent for those given chemotherapy alone, while median durations of response were 7.7 months and 4.8 months, respectively.
Merck disclosed last month that KEYNOTE-407 had met its joint primary endpoints. The company has also said the data have been submitted to the FDA as part of its filing seeking approval of Keytruda for use in the first-line treatment of patients with advanced squamous NSCLC.
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Meanwhile, in Roche's previously announced IMpower131 study, 1021 patients with stage IV squamous NSCLC not previously treated with chemotherapy were randomised to receive Tecentriq plus chemotherapy, or chemotherapy alone. The primary study goals were PFS and OS in the intent-to-treat population, with secondary endpoints including the percentage of patients with objective responses and duration of response.
Data from the study revealed that the median PFS was 6.3 months in the combination regimen group, versus 5.6 months for chemotherapy alone. Roche said the 12-month PFS rates were 24.7 percent in the combination group and 12 percent in the chemotherapy group. Meanwhile, the ORR in the combination group was 49 percent, compared to 41 percent in the chemotherapy arm, while median duration of response was 7.2 months and 5.2 months, respectively.
Roche officials suggested it is too soon to rule out Tecentriq as the most effective first-line therapy for lung cancer, given that multiple studies are ongoing. "There is often a rush to oversimplification in this area," said Dan O'Day, head of Roche's pharmaceutical unit, adding "we are going to need more data to answer these questions. There will need to be a personalised approach to treating this disease…you will not have a one-size-fits-all therapy."
Separately on Sunday, Merck announced at ASCO that in the KEYNOTE-042 trial, the use of Keytruda as monotherapy for the first-line treatment of locally advanced or metastatic NSCLC in patients with a PD-L1 tumour proportion score of at least 1 percent resulted in median OS of 16.7 months versus 12.1 months for chemotherapy.
For related analysis, see ViewPoints: Keytruda locks the door on competition (and they know it).
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