Roche announced that the US FDA has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”
This approval is based on an interim analysis from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3–4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.1
Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks. The supplemental Biologics License Application for the Tecentriq monotherapy was granted Priority Review, a designation given to medicines the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
In the US, Tecentriq has received four approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It is also approved in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer.
Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.