The Targeted Pulse: Don’t Miss the FDA’s Latest Treatment Decisions and What a Retrospective Study Revealed in Endometrial Cancer

A Step in The Right Direction With Capivasertib in PTEN-Deficient mHSPC

Capivasertib (Truqap) in combination with abiraterone acetate (Zytiga) and androgen deprivation therapy (ADT) showed significant improvement in radiographic progression-free survival for patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC), according to data from the phase 3 CAPItello-281 trial (NCT04493853). In the study, the combination was compared with placebo plus abiraterone and ADT. Although the overall survival (OS) data were immature at the time of analysis, investigators reported a trend favoring the capivasertib regimen.

“These results show for the first time that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient mHSPC,” said Susan Galbraith, executive vice president of Oncology research and development at AstraZeneca, in the press release. “By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary end points including OS.”

“A Significant Milestone” Is Achieved for LBS-007 in Acute Myeloid Leukemia

LBS-007 received fast track designation by the FDA for the treatment of patients with acute myeloid leukemia. The decision is based on data from a phase 1/2 trial (NCT05756322), evaluating LBS-007 in patients with relapsed or resistant acute leukemias. In the phase 1 portion of the study (the dose-finding phase) investigators are evaluating LBS-007 as a monotherapy and in combination with venetoclax (Venclexta) and azacitidine. During phase 2, the agent will be assessed as a monotherapy and in combination therapy at the dose identified in phase 1.

“We are thrilled to see LBS-007 showing signs of early treatment response and potential efficacy in addressing this critical unmet medical need,” said Tom Lin, MMED, PhD, MBA, chairman of Lin BioScience, in a press release. “Receiving FDA fast track designation is a significant milestone, offering an expedited pathway to advance the development of this promising therapy. We remain deeply committed to delivering transformative solutions for patients in need.”

RP1 Plus Nivolumab is One Step Closer To FDA Approval in Advanced Melanoma

A biologics license application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) has been submitted to the FDA. The application seeks approval for patients with advanced melanoma who have received previous treatment with a regimen containing a PD-1 inhibitor. The basis for this submission comes from the phase 1/2 IGNYTE trial (NCT03767348). The study is an open-label, dose-escalation and -expansion study evaluating safety and efficacy as primary end points.

In addition, a confirmatory phase 3 IGNYTE-3 trial (NCT06264180) is currently enrolling patients to assess RP1 in combination with nivolumab. Eligible patients include those with advanced melanoma who have progressed on anti–PD–1 and anti–CTLA-4 therapy or who are not candidates for anti–CTLA-4 treatment.

“Today is an important milestone for Replimune and for the melanoma community as we are 1 step closer to having another potential treatment available for patients who have limited options after progressing on anti–PD-1–containing regimens,” Sushil Patel, PhD, chief executive officer of Replimune, in a press release.

A Retrospective Review of Factors Delaying Care in Endometrial Cancer

A retrospective study assessing delays in care in endometrial cancer identified contributing factors. One of the primary delays came from the time between symptom onset and initial evaluation by a clinician, according to Alexander J. Fife, MD, clinical instructor at Rutgers New Jersey Medical School in Newark and one of the authors of the study. This delay was especially prominent in patients without an established relationship with a primary care physician. In this discussion, Fife explained the study findings and highlighted new useful tools that can help to mitigate these delays in care.

“I think the biggest intervention comes before patients are even seeing the primary care doctor; it is expanding access to primary care and getting more doctors to go into primary care. Again, there have been more incentives. A lot of medical schools have started offering expedited 3-year programs to increase the number of people entering primary care,” Fife told Targeted Oncology^TM in an interview.

Belantamab Mafodotin Combos Could Transform Multiple Myeloma With BLA Approval

The BLA application for belantamab mafodotin (Blenrep) has been accepted by the FDA. This application seeks approval for 2 combinations: belantamab mafodotin with bortezomib (Velcade) and dexamethasone, and belantamab mafodotin with pomalidomide (Pomalyst) and dexamethasone. The indication involves patients with multiple myeloma who have received at least 1 prior line of therapy. The basis for this application comes from data from the phase 3 DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) trials.

“Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable adverse events and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our [belantamab mafodotin] combinations submission has been further strengthened by the statistically significant OS results from the DREAMM-7 trial. We look forward to working with the FDA on this review,” said Hesham A. Abdullah, MD, MSc, senior vice president, global head oncology, research and development, GSK, in a press release.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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