The market for ovarian cancer treatments is expanding, with two new drugs recently approved and several novel candidates in clinical trials, according to a June 29 article. In February, Merck received U.S. Food and Drug Administration approval for Keytruda and its subcutaneous injection Qlex with paclitaxel for patients with platinum-resistant ovarian cancers. This combination led to a 24% reduction in the risk of death based on Phase 3 trial data. The following month, Corcept Therapeutics’ glucocorticoid blocker Lifyorli was approved for the same indication, showing a 35% reduction in risk of death when combined with nab-paclitaxel compared to chemotherapy alone.
Premal Thaker, director of gynecological oncology clinical research at Siteman Cancer Center, said both approvals were significant advancements for platinum-resistant ovarian cancer patients who have limited treatment options. Thaker is also leading the Phase 3 OVATION-3 trial investigating Imunon’s gene therapy IMNN-001 alongside chemotherapy. Recent Phase 2 results showed an increase in overall survival by nearly fifteen months compared to standard care.
Among emerging therapies are antibody-drug conjugates (ADCs), including GSK’s mocertatug rezetecan (Mo-Rez) targeting B7-H4 antigen and Tubulis’ TUB-040. Data from GSK’s BEHOLD-1 trial indicated objective response rates of over sixty percent in platinum-resistant cases. Eric Richards, senior vice president at GSK, said, “What we’re seeing is not only a high level of clinical activity but initial signs of pretty good durability.” Five Phase 3 trials evaluating Mo-Rez are planned this year across various forms of ovarian and endometrial cancers.
Zentalis Pharmaceuticals is testing its WEE1 inhibitor azenosertib in cyclin E1–positive patients through global Phase 3 studies after receiving Fast Track designation from the FDA last year. Early data presented at the American Society of Clinical Oncology annual meeting showed promising response rates regardless of cyclin E1 status.
OSE Immunotherapeutics reported positive proof-of-concept results for its vaccine Tedopi during maintenance treatment after chemotherapy among HLA-A2 positive patients with recurrent disease; however, statistical significance was not achieved on all endpoints, according to Alexandra Leary, lead investigator on the TEDOVA trial.
Allarity Therapeutics’ stenoparib—a dual-target PARP/tankyrase inhibitor—has also received Fast Track designation from the FDA and has shown extended overall survival beyond two years in some cases during ongoing trials. Jeremy R. Graff, Allarity's president and chief developmental officer, said: “It really seems to be particularly highly activated in really advanced, chemo- and radio-resistant cancers.” Graff added that there remains an unmet medical need: “We’d love to...go beyond just poisoning people with chemotherapy.”