FDA Gives Cancer Drug Updates, Prostate Cancer Trial Enrolls Patients

This week in oncology news, we saw a few decisions from the Food and Drug Administration, ranging from the agency agreeing to review a drug and potentially grant it a full approval to their citing manufacturing concerns for a gastric cancer drug.

Additionally, a small study showed 100% disease control rate in a subtype of non-Hodgkin lymphoma, and a clinical evaluation of a new prostate cancer drug will continue to enroll patients.

FDA Accepts sBLA For Tivdak in Recurrent or Metastatic Cervical Cancer

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to Tivdak for the treatment of patients with recurrent or metastatic cervical cancer that has progressed after first-line therapy. Tivdak, the first antibody-drug conjugate for this patient population, received accelerated approval in 2021. Now, the sBLA is for the continued approval, which is contingent upon clinical benefit verification in confirmatory trials.

Results from the phase 3 innovaTV 301 trial presented at the 2023 ESMO Congress demonstrated that Tivdak reduced the risk of death by 30% compared to chemotherapy as a second- or third-line treatment for this patient population. The trial also showed improvements in overall survival, progression-free survival, and confirmed objective response rate. Treatment-related side effects were observed in a majority of patients, with anemia and nausea being the most common.

The FDA plans on making a decision on the approval by May 9, 2024.

FDA Cites Manufacturing Concerns in Missed Gastric Cancer Drug Deadline

Also in FDA news from the week, the agency will not meet the Jan. 12, 2024, deadline for approving zolbetuximab, a drug designed for the treatment of unresectable or metastatic HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA attributed the delay to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” and issued a complete response letter to Astellas, clarifying that no clinical concerns, including safety and efficacy, were identified.

Zolbetuximab, a monoclonal antibody targeting the CLDN 18.2 protein overexpressed in certain gastric cancers, has shown promise in preclinical studies by inducing cell death in cancer cells. The drug had received a priority review from the FDA based on positive outcomes in the phase 3 SPOTLIGHT clinical trial and the GLOW clinical trial. Astellas, the manufacturer of the drug, is now collaborating with the FDA and the third-party manufacturer to address the identified issues and establish a timeline for resolving them.

Enrollment Continues in Study Evaluating ONCT-534 For Advanced Prostate Cancer

Patients are still being enrolled in an assessment of the novel drug, ONCT-534, for the treatment of advanced prostate cancer that has relapsed or is refractory to approved androgen receptor pathway inhibitors (ARPIs).

The study’s first two cohorts received daily oral doses of 40 mg and 80 mg of ONCT-534, while the third and fourth patients, part of the third cohort, will be administered a 160 mg daily oral dose.

The ongoing phase 1/2 ONCT-534-101 study aims to determine the drug’s safety, tolerability and preliminary antitumor activity, with a total of 27 patients in the first phase and two cohorts of 16 patients each in the second phase.

The study is anticipated to conclude in January 2028.

Novel Drug Shows 100% Disease Control Rate in WM

And finally, a novel drug, iopofosine I 131, showed a 100% disease control rate in patients with Waldenstrom’s macroglobulinemia, according to topline findings from the CLOVER WaM study.

The CLOVER WaM trial investigated iopofosine I 131 in 50 WM patients who had undergone at least two prior lines of therapy, including a BTK inhibitor. In an efficacy evaluable population of 41 patients who received a total dose of 60 mCi 60 or more days ago, the trial met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, with 100% experiencing disease control and 76% not experiencing disease progression at an average follow-up of eight months. Notably, 8% of patients achieved a stringent complete remission.

Now we should note, however, that this is a small study sample size of only 50 patients, so we would expect to see future studies evaluating this drug in a larger patient population.

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