Roche’s Tecentriq Bags Landmark FDA Approval as First-Line Monotherapy for Metastatic NSCLC
By T. Chakraborty, Ph.D.
Lung cancer is the leading cause of cancer inflicted deaths with an expected estimate of approximately 35,720 (72,500 men and 63,220 women) fatalities in 2020. Among the two types of lung cancers, Non-small-cell lung carcinoma (NSCLC) is the common one accounting for around 85% of total cases. Generally, the 5-year survival rate for lung cancer patients is 19% while those with NSCLC and SCLC are 24% and 6% respectively .
On May 19th, Roche’s Tecentriq (atezolizumab), a PD-L1 inhibitor received FDA approval as a first-line monotherapy treatment for adults with metastatic NSCLC. This approval marks Tecentriq’s monumental fourth indication in metastatic NSCLC and the fifth indication in lung cancer overall in the US.
Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development said, “We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions. Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease” .
Tecentriq, an anti-PD-1 Antibody
Although our immune system is programmed to safeguard us from foreign entities, it is sometimes capable of eliciting an excessive immune response. To overcome this, our cells produce immune checkpoint proteins. Unfortunately, cancer cells take advantage of these very proteins to bypass the host immune system.
Programmed cell death protein 1 or PD-1 is one such checkpoint protein expressed on the surface of T-cells. In order to bypass the host immune response, tumor cells overexpress its ligand, PD-L1. The binding of these two proteins dampens the immune response and the cytotoxic ability of T-cells. This Nobel Prize-winning discovery led to the progress of several immunotherapies that targeted immune checkpoint proteins.
Tecentriq is the world’s first single-agent cancer immunotherapy with three dosing options which allows administration into patients every two, three, or four weeks. Tecentriq has been previously approved in the US and Europe to be used as a single agent, combination drug along with other prevalent immunotherapies, targeted medicines, and other chemotherapies involving different types of cancers.
This FDA approval of Tecentriq is an outcome of positive results from the Phase 3 IMpower110 study, an open-label trial consisting of 572 patients. The study showed that Tecentriq monotherapy significantly improved the overall survival rate when compared with patients receiving traditional chemotherapy. Patients treated with the drug had an overall survival increase of 20.2 months as compared to 13.1 months for chemotherapy. Further, treatment-related adverse events were also significantly reduced in the drug arm. No new safety or efficacy problems were identified in this clinical trial [2,3].
Since the development of the drug in 2015, Tecentriq has quickly climbed up the ladder and has received multiple FDA approvals. Last year, the Tecentriq/Abraxane combo became the first approved immunotherapy for breast cancer . Further, multiple Phase 3 evaluations are ongoing for skin, gastrointestinal, gynecological, and head and neck cancer giving hope to millions of people.
Several companies have developed immunotherapies targeting these checkpoint proteins. Of special note, is Merck’s blockbuster drug Keytruda (pembrolizumab), a leader in the market. On a cautionary note, not all patients respond to PD-L1 inhibitors and therefore various assays have been approved by the FDA to predict patients who are likely to respond to PD-L1 inhibitors. Besides, companies including Roche is further investing in developing inhibitors that target other checkpoint proteins like TIGIT.
Editor: Rajaneesh K. Gopinath, Ph.D.
©www.geneonline.com All rights reserved. Collaborate with us: firstname.lastname@example.org