Roche presented detailed results from the Phase III IMpower133 study at the World Conference on Lung Cancer (WCLC) on Tuesday. The company said patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC) who were given its PD-L1 inhibitor Tecentriq (atezolizumab) plus standard chemotherapy lived significantly longer compared with chemotherapy alone, at 12.3 months versus 10.3 months, respectively. The results, which were simultaneously published in the NEJM, also showed that the combination significantly reduced the risk of disease worsening or death, with Tecentriq-treated patients achieving progression-free survival (PFS) of 5.2 months, versus 4.3 months for those on chemotherapy alone.
In the placebo-controlled study, 403 patients with ES-SCLC were randomised to first-line treatment with Tecentriq plus chemotherapy, consisting of carboplatin and etoposide, or chemotherapy alone. The co-primary endpoints of the study were investigator-determined PFS and overall survival (OS).
In other results, Roche said the one-year OS rate for the Tecentriq arm was 51.7 percent, compared to 38.2 percent for chemotherapy alone. Meanwhile, the objective response rate was 60 percent in the Tecentriq group, versus 64 percent for chemotherapy, while the median duration of response in these two groups was 4.2 months and 3.9 months, respectively.
Baader Helvea analysts have suggested that a potential "first-mover advantage" in SCLC could boost Tecentriq's peak revenue by $1.5 billion. Meanwhile, Roche CEO Severin Schwan has also identified Tecentriq, which had sales of 320 million Swiss francs ($331.6 million) in the first half, as a key asset for the company to help offset $21 billion in revenue at risk due to patent expirations for drugs including Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab). For related analysis, see ViewPoints: WCLC - Roche sets a new bar in small-cell lung cancer.
Earlier this week, Roche unveiled data from the Phase III IMpower132 study showing that Tecentriq in combination with Eli Lilly's Alimta (pemetrexed) and chemotherapy lowered the risk of disease progression or death in the first line-treatment of patients with non-squamous, non-small-cell lung cancer (NSCLC). The company announced recently that the FDA had extended its review of the filing for Tecentriq plus Avastin and chemotherapy in first-line metastatic non-squamous NSCLC by three months (for related analysis, see ViewPoints: Roche's regulatory setback for Tecentriq - delaying inevitable disappointment?).
Tecentriq has been approved in several markets for previously treated metastatic NSCLC, as well as for certain types of untreated or previously treated metastatic urothelial carcinoma.
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