CURE’s Clinical Trial Corner: June 2021

Breast Cancer

Patient enrollment is underway for a clinical trial in which the safety and efficacy of Cosela (trilaciclib) will be assessed in individuals receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer, according to the agent’s manufacturer, G1 Therapeutics.

The study is expected to include two groups of patients; one of which is anticipated to include 170 PD-1/PD-L1 naive patients receiving first-line treatment. The other group is expected to comprise 80 PD-L1 positive patients receiving second-line therapy following previous treatment with PD-1/PD-L1 inhibitors.

Measuring the effect of Cosela on overall survival compared to placebo in patients receiving front-line gemcitabine and carboplatin is the main goal of evaluating the first group. The assessment of the second group is to evaluate the therapy’s effect on overall survival in those receiving the chemotherapy combo as a second-line treatment in patients who already received PD-1/PD-L1 inhibitors.

“Gemcitabine (and) carboplatin has historically been one of the standard first-line regimens for patients undergoing chemotherapy for (metastatic triple-negative breast cancer),” said Dr. Joyce O'Shaughnessy, chair of breast cancer research at Baylor University Medical Center, in a news release. “In a phase 2 study, when (Cosela) was administered prior to this regimen, it enhanced antitumor efficacy compared to gemcitabine/carboplatin alone and improved overall survival with statistical significance. This is an important finding for patients with (metastatic triple-negative breast cancer), and for physicians who treat them.”

Liver Cancer

Medivir AB recently announced details of a planned clinical trial of one of its investigational drugs — MIV-818 — in patients with hepatocellular carcinoma whose disease progressed on, or was intolerant to, first-line standard treatment.

The plan, according to a news release from the manufacturer, is to assess MIV-818 in two groups of patients. The first group would receive the investigational drug combined with Keytruda (pembrolizumab), and the other group would receive MIV-818 in combination with Lenvima (lenvatinib). The first phase of the trial is expected to identify a recommended a phase 2 dose. Once that has been identified, more groups of up to 30 patients will be enrolled into another phase of the trial.

The release noted that the first patient is expected to be enrolled onto the trial in the second half of 2021.

Head and Neck Cancer

The protocol of a phase 2 trial has been amended to include an additional group of patients whose disease failed to respond to prior treatment with checkpoint inhibitors.

The VERSATILE-002 trial initially was opened to patients with checkpoint inhibitor-naive HPV16-associated head and neck cancer. Patients were being recruited to receive the investigational drug PDS0101 combined with Keytruda rather than chemotherapy as their first-line treatment for recurrent disease.

The study expanded to include a new group of patients which helps the researchers evaluate responses to the combination in approximately 40 patients with advanced disease who did not achieve a response to multiple treatments, including checkpoint inhibitors.

“There is an enormous unmet medical need in advanced head and neck cancer patients who have failed multiple therapies, including chemotherapy, radiation and checkpoint inhibitor therapy,” said PDS Biotech’s Chief Medical Officer Dr. Lauren Wood in a news release.

Solid, Hematologic Malignancies

ImCheck Therapeutics recently announced that the first patient in the United States has been dosed as a part of the company’s EVICTION clinical trial assessing the investigational therapy ICT01 as a monotherapy or in combination with anti-PD-1 inhibitors in patients with solid and hematologic malignancies.

The EVICTION trial is a basket trial designed to evaluate the preliminary safety and efficacy of the therapy as a single-agent or in combination. Patients with bladder, breast, colorectal, gastric, melanoma, ovarian, prostate and pancreatic cancer are enrolled onto the trial. Moreover, patients with acute myeloid leukemia, acute lymphoblastic leukemia, follicular lymphoma, diffuse large B-cell lymphoma and non-small cell lung cancer also make up the study participants.

“Current immunotherapies are proving to be beneficial for patients with some cancers, but we need new approaches and treatments to extend these advances to more patients,” Dr. Patricia LoRusso, the associate center director for innovative medicine at the Yale University Cancer Center and an investigator in the EVICTION trial, said in a news release. “I believe the gamma9 delta2 T-cell activation seen to date with ICT01 has great potential ….”

The clinical trial sites in the United States include Yale University Cancer Center, Moffitt Cancer Center and the University of Washington/Seattle Cancer Care Alliance.

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