Roche gets another US approval for 'Tecentriq'

Roche announced on Wednesday that the US Food and Drug Administration (FDA) has approved ‘Tecentriq’ - atezolizumab - in combination with chemotherapy - ‘Abraxane’ and carboplatin - for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumour aberrations.

The Swiss pharmaceuticals giant said the approval was based on results from the phase 3 ‘IMpower130’ study, which showed Tecentriq in combination with chemotherapy helped people live “significantly longer” compared to chemotherapy alone in the intention-to-treat wild-type (ITT-WT) population.

It said the Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone in the ITT-WT population.

Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, Roche said, and no new safety signals were identified with the combination.

Grade three to four treatment-related adverse events were reported in 73.2% of people receiving Tecentriq plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone.

In lung cancer, Tecentriq was also approved in the US in combination with ‘Avastin’ - bevacizumab - and chemotherapy for the initial treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.

Additionally, Tecentriq was approved by the FDA to treat adults with metastatic NSCLC who had disease progression during or following platinum-containing chemotherapy.

Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for NSCLC harbouring those aberrations prior to receiving Tecentriq, Roche explained.

Tecentriq was also approved in the US in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer.

Roche said it had an “extensive” development programme for Tecentriq, including nine phase 3 studies underway across different types of lung cancer, and multiple ongoing and planned phase 3 studies across genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.

That included studies evaluating Tecentriq both alone and in combination with other medicines.

“We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,” said Roche’s chief medical officer and head of global product development Levi Garraway.

“Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease.”