Genentech said the phase III IMpower130 study met its co-primary endpoints of overall survival and progression-free survival.
Genentech is a member of the Roche Group.
The combination of Tecentriq (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) helped people live significantly longer compared to chemotherapy alone in the initial treatment of advanced non-squamous non-small cell lung cancer.
In addition, the Tecentriq combination reduced the risk of disease worsening or death compared with chemotherapy alone. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming oncology congress.
Currently, Genentech has eight phase III lung cancer studies underway evaluating Tecentriq alone or in combination with other medicines. This is the third positive Phase III study evaluating TECENTRIQ alone or in combination to demonstrate an OS benefit for people with Tecentriq.
IMpower130 is a phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 724 people who were randomized equally (1:1) to receive:
TECENTRIQ plus carboplatin and nab-paclitaxel (Arm A), or
Carboplatin and nab-paclitaxel (Arm B, control arm)
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurs first.
People received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.
During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurs first.
People received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until disease progression.
The co-primary endpoints were:
PFS as determined by the investigator using RECIST v1.1 in all randomized people without an EGFR or ALK mutation (intention-to-treat wild-type)
OS in the ITT-WT population
IMpower130 met its OS and PFS co-primary endpoints.
