Roche's Tecentriq bursts onto immuno-oncology scene, with Merck and BMS in its sights

Roche Basel

Roche’s atezolizumab has joined the immuno-oncology party. Now dubbed Tecentriq, the PD-L1 drug won FDA approval to treat advanced bladder cancer in patients who’ve failed on platinum-based chemotherapy.

That puts Tecentriq among the few options for bladder cancer patients--and makes it the third PD-1/PD-L1 inhibitor to hit the market, behind Bristol-Myers Squibb’s Opdivo and Merck & Co.’s Keytruda.

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

For now, Tecentriq won’t be competing directly with Opdivo or Keytruda, because the Roche therapy is not yet approved for any of the same indications. But that could change soon: The FDA granted Tecentriq its “breakthrough” designation in lung cancer last month, putting it in line for a quick approval.

And in that field, Tecentriq would be squaring off against both meds, which have been in a neck-and-neck race to rack up lung cancer indications. For good reason: Non-small cell lung cancer is among the most common types of cancer, with millions of new patients diagnosed every year.

The bladder cancer approval is based on Phase II data on response rate and duration of response, Roche said in a Wednesday statement. The company is looking for confirmatory data in an ongoing Phase III trial, pitting Tecentriq against chemo in patients who’ve failed on a platinum regimen.

Roche sees a marketing edge for Tecentriq in its obvious benefits to patients who test positive for the PD-L1 biomarker. The drug specifically targets PD-L1, rather than PD-1 as Opdivo and Keytruda do, and 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.

Roche’s data shows that biomarker-positive patients respond most heartily to Tecentriq. With its own diagnostics arm--and long experience with other biomarker-targeted drugs, including the HER2+ med Herceptin--Roche thinks it can capture share despite its third-to-market status. And analysts agree that the drug will find its place; current estimates put peak sales at $2 billion to $3 billion.

Obviously, a lung cancer approval will be key to Roche’s ambitions. And the next few quarters will tell whether the Swiss drugmaker can turn its beliefs into real market-share gains. Bristol-Myers Squibb’s Opdivo has a commanding head start, and Merck’s med is racking up solid sales, too.

Indeed, Merck’s second-place status could be a cautionary tale for Roche. Right now, Keytruda is approved for patients who test positive for PD-L1 expression, and some physicians have proven reluctant to order the diagnostic test and wait for the results to prescribe a med. Some apparently are prescribing Opdivo instead.

Then again, Merck’s groundwork on pushing the diagnostic--a considerable effort, the company says--could end up helping Roche, too. If PD-L1 testing does become the standard of care in lung cancer, then drugs with that specific indication could benefit. Though Opdivo does tend to work better in PD-L1-positive patients, its early trials weren’t designed to prove that fact.

Meanwhile, the trio could face another contender soon enough. AstraZeneca ($AZN) has the fourth checkpoint inhibitor--also a PD-L1--lining up for an approval. But that med, durvalumab, has fallen behind, time-wise, and could find it difficult to carve out a niche when it comes to market.

- see the Roche release

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