Roche's Tecentriq scores lung cancer nod, setting up 3-way battle with Merck, BMS

Roche’s new immuno-oncology drug Tecentriq is ready for its close-up in lung cancer. The PD-L1 checkpoint inhibitor nabbed FDA approval for patients who’ve failed on a previous treatment, putting it in head-to-head competition with Merck & Co.’s Keytruda and Bristol-Myers Squibb’s Opdivo.

Tecentriq was already approved to treat bladder cancer, but the lung cancer field is a much larger market. Though Keytruda and Opdivo have already made inroads, analysts see a solid opportunity for Tecentriq, particularly after strong survival data presented last week at the European Society for Medical Oncology meeting in Copenhagen.

In Phase III data presented at ESMO, Tecentriq improved overall survival among previously treated non-small cell lung cancer patients by a median 4.2 months over chemo. Patients in the Tecentriq arm lived a median 13.8 months, topping a 9.6-month figure for chemo. The Tecentriq figure was "essentially unprecedented," Dan Chen, head of cancer immunotherapy development at Genentech, told FiercePharma. He added that the number "suggests that Tecentriq really does have a powerful survival effect.”

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Roche is the world’s leader in cancer treatments and has strong relationships in the oncology field that should help it win doctors over to its new med. The Swiss drugmaker also sees Tecentriq’s particular target--PD-L1, versus PD-1 for its competitors--as a way to differentiate it from Keytruda and Opdivo.

“Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works,” Sandra Horning, Roche CMO and head of product development, said in a statement.

After Roche rolled out top-line data from its OAK trial last month, Bernstein analyst Tim Anderson said immuno-oncology “is now a three company affair” and Roche’s Genentech is now a “strong competitor with an established commercial presence and marketing muscle to offset its third-to-market entry timing.”  

EvaluatePharma expects Tecentriq to be the 14th best-selling drug in the world in 2022, with $5.3 billion in sales that year.

The Roche drug’s FDA-approved label is a broad one. It applies to patients whose disease has progressed after platinum chemotherapy or after a targeted treatment for those whose tumors test positive for EGFR or ALK abnormalities. As with BMS’ Opdivo, Tecentriq patients do not have to be screened for the PD-L1 biomarker before treatment. In this second-line group, Keytruda patients have to hit a particular threshold for PD-L1 to qualify.

That lack of a testing requirement will help Tecentriq gain traction, Anderson said last week, and help offset its third-to-market status. “While this would not change the timing of market access, it would strengthen its market impact,” the analyst said.

Bernstein’s own estimates put Tecentriq at $4.9 billion by 2021. It is forecasting Opdivo at $8.1 billion and Keytruda at $6.5 billion, with AstraZeneca’s yet-to-be-approved PD-L1 checkpoint inhibitor running a distant fourth, but still a blockbuster, at $1.8 billion.  

Tecentriq’s list price is $12,500, on par with its rivals. 

Unlike Keytruda and Opdivo, which target the PD-1 protein, Tecentriq specifically targets PD-L1. Roche sees the PD-L1 target as a more significant driver of disease. The company figures it has a good chance of proving that Tecentriq can have a more durable effect on cancer than its rivals, with a lower likelihood of toxicity, FierceBiotech reported last year.

Special Report: The top 20 drugs in 2020--worldwide sales - Opdivo - Keytruda

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