- Merck & Co.’s Keytruda has succeeded in a Phase 3 trial in early kidney cancer, the drugmaker announced Thursday, in the latest example of the ongoing push to use immunotherapies in earlier lines of cancer care.
- Without disclosing details, Merck said Keytruda kept patients' tumors in remission longer than a placebo when administered in the so-called adjuvant setting — after surgery to remove a kidney or metastatic lesions — upon an interim look at a study called Keynote-564. The trial hasn't gone on long enough for Merck to tell if Keytruda extended patients' lives, however.
- Merck plans to submit the results to regulators, positioning Keytruda to become the first immunotherapy cleared for use in early kidney cancer. But several others could soon follow, as rival drugs from AstraZeneca, Bristol Myers Squibb and Roche are each in late-stage tests of their own.
Immunotherapy has quickly become a mainstay in the treatment of patients with advanced kidney cancer, as it has with tumors of the skin, lungs and more. Over the past few years, Keytruda and Bristol Myers' Opdivo have each been cleared for use, alongside other drugs, as first-line treatments for patients whose disease has spread.
But a concerted push is underway to move immunotherapy into earlier lines of care, either before surgery — what's known as the neoadjuvant setting — or afterwards. This shift has already begun in melanoma, where Keytruda and Opdivo are both approved as adjuvant treatment. And it is set to gain momentum, with dozens of adjuvant and neoadjuvant trials underway in breast, lung and other cancers. (The Food and Drug Administration recently rejected Keytruda in neoadjuvant breast cancer and asked for more data, however.)
Immunotherapy’s progression into earlier stages of cancer isn’t without controversy. The drugs don’t work for everyone, and their arrival in such settings would drive up costs of care, as many adjuvant treatments — like chemotherapy — are generic and cheap.
For drugmakers, these treatment settings are seen as significant, untapped revenue opportunities. In kidney cancer, for instance, more than 80% of patients are diagnosed before their disease has spread widely, according to the National Cancer Institute's SEER database. The only approved treatment in the adjuvant setting is Sutent, an enzyme-blocking drug from Pfizer, but that could be on the verge of changing, starting with Keytruda.
Merck didn’t disclose the details underlying its findings in the 950-patient study, but said that its drug led to a "statistically significant and clinically meaningful" improvement versus placebo in what's known as disease-free survival, a measure of cancer recurrence.
That result came a year earlier than expected, and will be submitted to regulatory authorities, Merck said in a statement. Both Opdivo and Keytruda were cleared in adjuvant melanoma on disease-free survival measures. As with Keytruda in kidney cancer, they hadn't yet shown they can extend patients' lives.
Competition may not be far off, though. The late-stage Immotion-010 study of Roche's Tecentriq should produce results by early 2022. Phase 3 trials testing Bristol Myers and AstraZeneca drugs could also read out by 2023 and 2024, respectively.
Meanwhile, clinical results from adjuvant or neoadjuvant trials of Keytruda in melanoma, head and neck cancer, and tumors of the stomach and esophagus are all expected by 2023.