CURE’s Clinical Trial Corner: May 2021

Lymphoma

The first patient has been dosed in a phase 3 study evaluating the safety and efficacy of adding Monjuvi (tafasitamab-cxix) and lenalidomide to the regimen of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as a first-line treatment in high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL), according to a news release from Incyte and MorphoSys AG.

“While more than half of DLBCL patients can be cured with an aggressive chemotherapy regimen, current outcomes for high-risk patients are poor,” said MorphoSys’s Head of Global Drug Development Dr. Mike Akimov in the release. “We believe we may be able to make a difference for those DLBCL patients by adding the combination of (Monjuvi) and lenalidomide to R-CHOP, a current standard of care.”

Although R-CHOP is considered a standard-of-care for this patient population, approximately 40% of patients either fail to achieve a response or relapse after treatment, according to the release.

Of note, the Food and Drug Administration in 2020 approved Monjuvi plus lenalidomide to treat adults with relapsed/refractory DLBLC who were ineligible for receiving an autologous stem cell transplant. Shortly after that approval was announced, an expert spoke with CURE® to discuss how important this combination would be for those individuals.

Lung Cancer

G1 Therapeutics recently announced that patient enrollment was underway for a phase 2 study assessing the second- and third-line treatment of Cosela (trilaciclib) prior to the administration of the chemotherapy docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) who had previously received treatment with a checkpoint inhibitor of chemotherapy.

“(NSCLC) is the most common type of lung cancer, accounting for nearly 85% of all diagnoses, and remains a great unmet medical need,” said Dr. Raj Malik, chief medical officer at G1 Therapeutics, in a news release. “Despite improvements in therapy for metastatic NSCLC, including the use of PD-1 or PD-L1 inhibitors, the majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy. In addition to the need for therapies that more effectively extend overall survival, patients treated in the metastatic setting are particularly vulnerable to chemotherapy-induced myelosuppression and health-related quality of life impacts associated with systemic chemotherapy.”

Approximately 146 patients are expected to be enrolled onto the study. The main goal of the trial, according to the release, is to evaluate the overall survival improvement with Cosela compared to placebo. Other goals include measuring progression-free survival benefit, overall response rate and duration of response.

Endometrial Cancer

Context Therapeutics and Jefferson Health’s Sidney Kimmel Cancer Center recently announced the dosing of the first patient in a phase 2 study assessing the effect of adding onapristone extended release to the hormone-based chemotherapy anastrozole in patients with metastatic endometrial cancer who previously failed treatment.

“The majority of endometrial cancer patients have hormone-driven cancer. Both estrogen and progesterone drive progression in those patients, and antiestrogens, most often anastrozole, have proven, albeit limited, activity,” said Dr. Russell Schilder, a co-principal investigator and director of the Gynecologic Medical Oncology Program at Sidney Kimmel Cancer Center, in a news release. “We will evaluate whether combining anastrozole with (onapristone extended release) will achieve more complete hormone blockade compared with anastrozole alone, which may lead to better outcomes for patients.”

Measuring the overall response rate (defined as proportion of patients who experience a partial or complete response to therapy) to the study treatment is the main goal of the study. The aim, according to the release, is to enroll approximately 25 patients who express the estrogen receptor and/or progesterone receptor biomarker. Additional goals of the study are to measure duration of response and progression-free survival.

Ovarian Cancer

Aspira Women’s Health and The Feinstein Institutes for Medical Research recently announced the two will begin a study to aid in the monitoring of women with benign adnexal masses — growths that occurs in or near the uterus, ovaries, fallopian tubes, and the connecting tissues — and detection of early-stage ovarian cancer.

“This study is two-fold, one is to vastly increase our enrollment to clinically validate the serial monitoring aspect OVASight test for all women who present with a mass and hereditary breast and ovarian cancer syndrome, and second, enrich our research and innovation pipeline,” said Aspira Women’s Health Chief Scientific Officer Lesley Northrop in a news release. “I am incredibly excited to work with the Feinstein Institutes in enhancing our biobank of biological samples and clinical data metrics. This will allow us the ability to evaluate additional biomarkers including ctDNA, RNA and proteins to apply as a multi-modal approach in early diagnosis of ovarian cancer as a liquid-biopsy based test.”

The aim is to enroll more than 600 women with adnexal masses, as well as more than 2,000 women considered at high risk for developing ovarian cancer.

One of the goals of the study, according to the release, is identify additional genomic markers to help develop a specific test for the early detection of ovarian cancer.

“Having testing options for women with benign masses to monitor them over time, as well as having a solution for assessing risk in high-risk women will provide meaningful insights for providers treating these women,” said Dr. Elena Ratner, a gynecologic oncologist and global chief medical advisor, clinical and translational medicine at Aspira Women’s Health, in the release.

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