- Roche said its immunotherapy Tecentriq, when given after surgery alongside chemotherapy, helped lung cancer patients stave off the return of their disease longer than standard treatment alone. The results give Roche the chance to have the first drug in its class to be used in the so-called adjuvant setting, when treatments aim to keep cancer at bay.
- The Swiss drugmaker didn't provide specific details, but said the drug's benefit was most pronounced in patients whose tumors express a key protein, PD-L1, known to predict response to immunotherapy. It's unclear to what extent Tecentriq can help all other patients, including those whose tumors don't express PD-L1.
- Immunotherapies are widely used to treat lung cancer patients with late-stage disease. But earlier lines of therapy represent a lucrative opportunity. Tecentriq, for instance, could potentially earn up to $720 million in yearly sales as an adjuvant treatment, according to Jefferies analyst Peter Welford. That outlook could be altered by the entry of Merck & Co.'s Keytruda, which is also being tested in early disease and is the top-selling immunotherapy in lung cancer.
After rapid expansion into multiple disease types, immunotherapies known as checkpoint inhibitors have had a challenging few months. Ramped up scrutiny from the Food and Drug Administration has led drugmakers to withdraw checkpoint blockers in several cancer types — such as Tecentriq in bladder cancer — and the agency is convening an advisory committee next month to determine whether to uphold six additional accelerated approvals.
Tecentriq's success in adjuvant non-small cell lung cancer treatment, then, should offer some comfort to Roche, giving the drugmaker a new avenue to grow revenues.
The IMPower010 study evaluated a group of 1,005 patients whose cancer hadn't spread much beyond the lung, could be removed with surgery, and were then treated with up to four cycles of chemotherapy. After that, half received Tecentriq plus chemotherapy. The other half got chemotherapy alone.
Following an interim look, the trial's data monitoring board said Tecentriq had met its primary goal and extended the amount of time patients with PD-L1 positive tumors survived without any signs of symptoms of disease.
In the broader patient population, Roche said the Tecentriq group did not "cross the threshold" of statistical significance for disease free survival upon interim analysis. Nor had another secondary goal, extending survival, been met. However, Roche will continue to evaluate those endpoints until the trial's final analysis, the company said.
Assuming the FDA approves Tecentriq in this setting, Roche might soon have competition. Keytruda's KEYNOTE-091 study is expected to deliver results sometime this year, and because it is used widely in metastatic disease as a first-line treatment, would likely be a preferred choice by many lung-cancer specialists, Welford wrote in a March 22 note.
But both Roche and Merck could face challenges until they clearly show adjuvant treatment can help patients live longer. Lung-cancer specialists surveyed by Jefferies revealed they may be reluctant to use immunotherapies after surgery until survival data is available.