Tecentriq Triple Combo Under FDA Review for NSCLC Treatment
Genetech has announced that the U.S. Food and Drug Administration (FDA) will be reviewing its Tecentriq (atezolizumab) combined with chemotherapy drugs Abraxane (nab-paclitaxel) and carboplatin for treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The drug will be for patients without any mutations in the EGFR and ALK genes.
Tecentriq is a checkpoint inhibitor drug that targets the PD-L1 protein. Because cancerous cells use their own PD-L1 and bind to the PD-1 receptor on immune cells, they can avoid the immune system’s attack. Checkpoint inhibitor therapies get in the way of the binding so that the body’s immune system can actually fight against tumor cells.
Genetech applied for this drug approval after data from a Phase 3 clinical trial named IMpower130 showed that Tecentriq combined with chemotherapy (Abraxane and carboplatin) increased survival and slowed disease progression. The trial involved 724 metastatic NSCLC patients who were virginal to treatment. 483 patients were randomly selected to receive the Tecentriq triple-combination and 241 patients were selected to receive chemotherapy only.
Patients were given up to six cycles of chemotherapy and then continued to receive Tecentriq until disease progression. The control group patients also received maintenance treatment with Alimta (pemetrexed), and some patients were offered the option to switch over to Tecetnriq until they saw further disease progression.
The trial sought to determine if Tecentriq was able to increase overall survival rates and slow disease progression for a longer period of time than chemotherapy. Both of these outcomes were successful, as researchers saw patients’ life extensions increase from 13.9 months to 18.6 months, and saw a reduction of disease progression or death by 36%.
The data showed that the Tecentriq combination therapy was as safe as the individual components. 73.2% of patients who received the Tecentriq triple-combination underwent life-threatening adverse effects compared to 60.3% of patients who received chemotherapy alone.
Tecentriq combined with Avastin (bevacizumab) and the chemotherapies Taxol (paclitaxel) and carboplatin was previously approved by the FDA as treatment for non-squamous NSCLC patients without EGFR or ALK mutations in their tumors. The review of this new combination is expected to be completed by September 2, 2019.