Germany-based Merck KGaA and its partner Pfizer yesterday announced they have interrupted the Phase III Javelin Ovarian 100 clinical trial, since data from an interim analysis have shown the tested treatment won’t reach its primary endpoints. Javelin has been conducted on 998 patients with ovarian cancer, treated with immunotherapy Bavencio (avelumab), a PD-L1 inhibitor, as a first-line treatment vs chemotherapy.
This is the second trial assessing Bavencio to fail to reach its primary endpoints, indeed the company in November announced that the Javelin Ovarian 200 trial, conducted on patients with ovarian cancer already unsuccessfully treated with chemotherapy, had not achieved the expected results.
This is a very negative signal, as it confirms that no efficacious immunotherapies are currently available to treat ovarian cancer: indeed, all the clinical trials carried out by large pharmaceutical companies working on this disease have failed. Ovarian cancer is the sixth most common cancer type, and one of the most malignant and challenging ones, with a 50% survival rate.
Bavencio is among Merck’s high-priority new therapies–indeed, the Darmstadt-based group has as many as 6 other Phase III clinical trials ongoing with the product. The other high-priority product is multiple sclerosis drug Mavenclad. Going forward, the two therapies are expected to compensate for the revenue loss due to blockbusters Rebif (MS) and Erbitux (cancer) becoming mature.