Xagena.net


The phase III IMpower150 study met its co-primary endpoint of progression-free survival ( PFS ) and demonstrated that the combination of Atezolizumab ( Tecentriq ) and Bevacizumab ( Avastin ) plus chemotherapy ( Paclitaxel and Carboplatin ) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death ( PFS ) compared to Bevacizumab plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer ( NSCLC ).

Initial observations for the co-primary endpoint of overall survival ( OS ) are encouraging. These data are not fully mature and the next overall survival analysis is expected in the first half of 2018.

Safety for the Atezolizumab and Bevacizumab plus chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

IMpower150 is a multicentre, open-label, randomised, controlled phase III study evaluating the efficacy and safety of Atezolizumab in combination with chemotherapy with or without Bevacizumab in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people of which those with ALK and EGFR mutations were excluded from the primary ITT analysis.
People were randomised ( 1:1:1 ) to receive: Atezolizumab plus Carboplatin and Paclitaxel ( Arm A ), or Atezolizumab and Bevacizumab plus Carboplatin and Paclitaxel ( Arm B ), or Bevacizumab plus Carboplatin and Paclitaxel ( Arm C, control arm ).

During the treatment-induction phase, people in Arm A received Atezolizumab administered intravenously at 1200 mg in combination with intravenous infusion of Carboplatin and Paclitaxel on day 1 of a 3-week treatment cycle for 4 or 6 cycles.
Following the induction phase, people received maintenance treatment with Atezolizumab ( 1200 mg every 3 weeks ) until loss of clinical benefit or disease progression.
People in Arm B received induction treatment with Atezolizumab ( 1200 mg ) and Bevacizumab administered intravenously at 15 mg/kg in combination with intravenous infusion of Carboplatin and Paclitaxel on day 1 of a 3-week treatment cycle for 4 or 6 cycles. People then received maintenance treatment with the Atezolizumab - Bevacizumab regimen until disease progression ( Bevacizumab ) or loss of clinical benefit / disease progression ( Atezolizumab ).
People in Arm C received induction treatment with Bevacizumab administered intravenously at 15 mg/kg plus intravenous infusion of Carboplatin and Paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. This was followed by maintenance treatment with Avastin alone until disease progression.

The co-primary endpoints were progression-free survival, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 ( RECIST v1.1 ), and overall survival.

This analysis of the IMpower150 PFS endpoint was only statistically powered to demonstrate a comparison between Arm B versus Arm C.
The primary analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation ( intention-to-treat wild-type ) and in a subgroup of people who had a specific biomarker ( T-effector Teff gene signature expression ).
IMpower150 met its PFS co-primary endpoint per study protocol for both populations assessed.

Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab may enable the activation of T cells.

Bevacizumab is a biologic cancer treatment approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives.
Bevacizumab is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival. ( Xagena )

Source: Roche, 2017

XagenaMedicine2017