Roche's Genentech unit reported Monday an interim analysis from the Phase III IMpower132, showing that Tecentriq (atezolizumab) plus Eli Lilly's Alimta (pemetrexed) and platinum-based chemotherapy for the initial treatment of people with non-squamous, non-small-cell lung cancer (NSCLC) reduced the risk of disease worsening or death by 40 percent compared with chemotherapy alone. The company noted that progression-free survival (PFS) in the two groups was 7.6 months and 5.2 months, respectively.
Results, which were presented at the World Conference on Lung Cancer (WCLC), also demonstrated that OS for the PD-L1 inhibitor plus chemotherapy was 18.1 months, compared to 13.6 months for chemotherapy alone. Roche said that while this represented a numerical improvement of 4.5 months for OS, significance has not been met at the interim analysis, with final results expected next year.
Roche chief medical officer Sandra Horning remarked "this is our third Phase III trial in non-squamous non-small cell lung cancer demonstrating that a Tecentriq-based regimen can help reduce the risk of disease progression for people living with this disease," adding "we will discuss these results with health authorities globally."
In March, Roche unveiled late-stage clinical data of the IMpower150 study illustrating that Tecentriq in combination with Avastin and chemotherapy prolonged survival in the first-line treatment of patients with metastatic non-squamous NSCLC.
Earlier this year, Merck & Co. announced that in the KEYNOTE-189 trial, the combination of Keytruda (pembrolizumab), Alimta and chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC significantly improved OS, reducing the risk of death by 51 percent compared with chemotherapy alone. Results showed that patients who received only chemotherapy lived for a median of 11.3 months, while OS in those given Keytruda has not yet been reached. In addition, Keytruda was associated with a 48-percent decrease in the risk of disease worsening versus chemotherapy, with median PFS of 8.8 months compared with 4.9 months for chemotherapy.
The results come after Roche recently disclosed that the FDA had extended its review of the combination of Tecentriq plus Avastin and platinum chemotherapy for the first-line treatment of metastatic non-squamous NSCLC by three months. The agency had previously granted priority review to the filing (for related analysis, see ViewPoints: Roche's regulatory setback for Tecentriq - delaying inevitable disappointment?).
Tecentriq is currently approved in the EU, US and over 70 countries for people with previously treated metastatic NSCLC, as well as for certain types of untreated or previously treated metastatic urothelial carcinoma.
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