SWITZERLAND – The EU’s drug advisory body has recommended approval of Tecentriq (atezolizumab) as an adjuvant treatment in adult patients with early non-small-cell lung cancer (NSCLC) following complete resection and platinum-based chemotherapy, according to Roche.
In addition, the company received approval for its T-cell engaging CD20xCD3 bispecific mosunetuzumab in follicular lymphoma, with an EU approval potentially coming before a decision in the US.
Concerning the Tecentriq application, the European Union’s Committee for Medicinal Products for Human Use (CHMP) supports the drug for patients who have 50% PD-L1 expression and are considered to be at high risk of relapse.
“After a decade of limited treatment advances, many people in Europe with early NSCLC will soon have a new treatment option to reduce the risk of their disease recurring,” said Levi Garraway, chief medical officer at Roche.
Tecentriq became the first cancer immunotherapy approved for adjuvant NSCLC in the United States last October, when the FDA approved it for early disease, following resection and platinum-based chemotherapy, in patients with PD-L1 expression on 1% of tumor cells.
It has also been approved in China for this indication, and three countries, including Canada and the United Kingdom, have cleared it for adjuvant use in PD-L1-high NSCLC patients.
The CHMP recommendation was based on the Phase III IMpower010 study results. Tecentriq, according to Roche, reduced the risk of disease recurrence or death (DFS) by 57% in patients with Stage II-IIIA.
The DFS was observed in NSCLC whose tumors express high levels of PD-L1 but do not have Epidermal growth factor receptor mutant or Anaplastic lymphoma kinase (ALK)-positive disease when compared to best supportive care.
According to the company, a disease-free survival benefit was observed across most subgroups, including histology and stage of disease.
Overall survival (OS) data for this patient population are immature, according to Roche, and were not formally tested at the DFS interim analysis, despite “a trend toward OS improvement” with Tecentriq, with a hazard ratio of 0.36.
Analyses of more mature OS data are planned later this year. Meanwhile, Roche stated that if mosunetuzumab is approved, it will be the first CD20xCD3 T-cell engaging bispecific antibody available to treat follicular lymphoma.
The positive CHMP opinion is based on findings from the Phase I/II GO29781 study, in which mosunetuzumab was found to induce durable responses in heavily pretreated patients who had received at least two prior therapies, with a 60% complete response rate and a median progression-free survival of 17.9 months.
In February, Biogen exercised an option to participate in the development of mosunetuzumab as part of a long-standing collaboration with Roche’s Genentech unit on antibodies targeting CD20.
At the time, Biogen indicated that Genentech planned to complete a filing to the FDA for mosunetuzumab in relapsed/refractory follicular lymphoma “in the near future.”