Three's a crowd: Tecentriq gets lung cancer nod
- Genentech, the biotech arm of Swiss pharma Roche, on Tuesday announced its checkpoint inhibitor Tecentriq (atezolizumab) won approval from the Food and Drug Administration for treatment of metastatic pretreated non-small cell lung cancer (NSCLC)
- Approval was based on data showing treatment with the PD-L1 inhibitor helped patients live a median of 4.2 months longer than those treated with docetaxel chemotherapy. Importantly, the positive effect held up regardless of patient PD-L1 status.
- Jefferies predicts annual sales of $600 million for Tecentriq as a NSCLC monotherapy by 2020. It will have some ground to make up as Merck's Keytruda (pembrolizumab) and Bristol-Myer's Opdivo (nivolumab) have built a sizeable lead. But Opdivo's failure in first-line NSCLC could open the door for Roche.
With FDA approval, Roche's Tecentriq is now the third drug targeting the PD-1/L1 pathway to hit the market for second-line treatment of (NSCLC).
"Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy," said Sandra Horning, chief medical officer at Roche Genentech.
Unlike Keytruda and Opdivo, Tecentriq blocks the PD-L1 protein rather than the PD-1 protein. PD-1, a receptor, sits on the surface of immune cells while PD-L1 is expressed on the surface of many tumor cells and is a ligand for PD-1.
Inhibiting the interaction between the two by targeting either one can boost the immune system to attack tumor cells. Roche predicts patients would likely be tested for PD-L1 levels before first-line treatment with a checkpoint inhibitor but not before second-line treatment. Roche has received approval for the Ventana PD-L1 assay but this is not a requirement of treatment.
Analysts at Jefferies, predictably, regard the first-line setting as the most commercially significant market. Roche is carrying out a number of Phase 2 and Phase 3 studies for Tecentriq as a monotherapy and combination therapy, in both pretreated and first line patients.
PD-L1 expression levels have become a key consideration in expanding labels for the new immuno-oncology drugs. In Bristol-Myers' high-profile first-line failure, Opdivo failed to beat out chemotherapy in a broad population of patients expressing PD-L1 at levels higher than 5%. Merck, in contrast, tested Keytruda only in patients with PD-L1 levels higher than 50% and saw improved improved progression-free and overall survival.
Jefferies predicts the greater level of data in third-line patients and the dosing every three weeks for Tecentriq, compared with every two weeks for Opdivo and Keytruda, might give Tecentriq an eventual edge.
- Roche Statement
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