Context Therapeutics and Jefferson Health to Evaluate Apristor Combination Therapy for Women with Advanced Endometrial Cancer
Apristor, an oral progesterone receptor antagonist, is being studied in combination with an antiestrogen in advanced ER+,PR+,HER2- endometrial cancer. Study to determine if complete hormone blockade provides enhanced outcomes for patients.
Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, today announced a Phase 2 clinical collaboration with the Sidney Kimmel Cancer Center at Jefferson Health. This clinical collaboration will evaluate whether the addition of Apristor to the antiestrogen, anastrazole, can enhanced outcomes for patients with metastatic endometrial cancer who have failed multiple prior therapies.
The Phase 2 trial will assess an oral treatment consisting of the progesterone receptor antagonist, Apristor (onapristone ER) plus the antiestrogen, anastrazole, in up to 25 patients who are ER+,PR+,HER2- and who have received prior chemotherapy treatment. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of Apristor, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of oral combination in these patients, as well as biomarker analyses to explore predictive factors of response to complete hormone blockade. This data will support Context’s ongoing Phase 2 studies and help design a future Phase 3 trial.
“Currently, there are limited therapeutic options to treat endometrial cancer in the advanced setting. Recent preclinical findings, together with Phase 1 study results in patients with advanced PR+ ovarian and endometrial cancers, give us reason to believe that Apristor can help women with PR+ gynecological cancers,” said Martin Lehr, CEO of Context Therapeutics. “We believe Apristor can make a meaningful difference for patients in the trial.”
The study, sponsored by Jefferson Health, will be led by the Primary Investigator, Dr. Saveri Bhattacharya, an Assistant Professor of Medical Oncology. Dr. Russell Schilder, Director of the Gynecologic Oncology Program, and Dr. Kimberly Aderhold are the study’s Co-Investigators. Final study design and other details will be announced upon enrollment of the first patient, expected around the end of 2019 or early 2020.
“Context is humbled by the support and enthusiasm of Dr. Bhattacharya and her colleagues at Jefferson,” said Mr. Lehr. “The gynecologic oncology program at Jefferson is one of the top in the country and we are fortunate that Jefferson is right in our backyard.”
“The majority of endometrial cancer patients have hormone driven cancer. The hormones estrogen and progesterone drive endometrial cancer progression in those patients, but antiestrogens are the only antihormonal therapy available to clinicians. Given the broad use of antiestrogens, antiestrogen resistance is now a major clinical challenge,” said Dr. Bhattacharya. “We believe that a progesterone receptor antagonist has the potential to address antiestrogen resistance by working with an antiestrogen to deprive the cancer of hormone driven growth signals, which will lead to better outcomes for patients.”
