The FDA ( US Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) in combination with chemotherapy ( Abraxane [ Paclitaxel protein-bound; nab-Paclitaxel ] 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.
This approval is based on results from the phase III IMpower130 study, which has shown Atezolizumab in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone ( median overall survival [ OS ]=18.6 versus 13.9 months; hazard ratio [ HR ]=0.80; 95% CI: 0.64–0.99; p=0.0384 ) in the intention-to-treat wild-type ( ITT-WT ) population.
The Atezolizumab-based combination has also significantly reduced the risk of disease worsening or death ( progression-free survival [ PFS ] ) compared with chemotherapy alone ( median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.63–0.91; p=0.0024 ) in the ITT-WT population.
Safety for the Atezolizumab plus chemotherapy combination is appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving Atezolizumab plus chemotherapy compared with 60.3% of people receiving chemotherapy alone.
In lung cancer, Tecentriq is also approved in the US in combination with Avastin ( Bevacizumab ), Paclitaxel and Carboplatin ( chemotherapy ), for the initial treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.
Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have 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 these aberrations prior to receiving Tecentriq.
Tecentriq is also approved in the US in combination with Carboplatin and Etoposide ( chemotherapy ) for the initial treatment of adults with extensive-stage small cell lung cancer ( ES-SCLC ).
IMpower130 is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Atezolizumab in combination with nab-Paclitaxel and Carboplatin versus chemotherapy ( nab-Paclitaxel and Carboplatin ) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC.
During the treatment-induction phase, people in Arm A have received Atezolizumab 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 occurred first.
People in Arm A received Atezolizumab 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 occurred first. People in Arm B 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 Atezolizumab as monotherapy until further disease progression.
The co-primary endpoints were: progression-free survival ( PFS ), as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations ( ITT-WT population ), and overall survival ( OS ) in the ITT-WT population.
Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1, which is 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.( Xagena )
Source: Roche, 2019