The Targeted Pulse: FDA’s ODAC Mandates New Phase Assessment Protocols in NSCLC, Dendritic Cell Vaccine Gains Ground in Pancreatic Cancer, and More

Blazing Trails in NSCLC: FDA’s ODAC Mandates New Phase Assessment Protocols

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to require that new trial designs for perioperative treatments of resectable non–small cell lung cancer (NSCLC) include an evaluation of the impact of each treatment phase. Committee members discussed issues from the AEGEAN trial (NCT03800134), which evaluates durvalumab in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery. They debated whether an additional trial is needed to clarify the regimen’s contribution before approval.

“Part of the discussion today is if additional data are needed prior to approval of the AEGEAN regimen. It is a sponsored position that AEGEAN has already convincingly demonstrated a clinical benefit,” said Leora Horn, MD, MSC, MHPE, FRCPC, during her closing remarks. “AstraZeneca is committed to address some of the remaining questions in resectable NSCLC, with new studies anticipated to enroll first subjects later this year. Future studies in resectable NSCLC cancer need to consider the drug’s mechanism of action, trial feasibility, the treatment landscape, patient's preference, and societal burden.” Horn is global clinical head for Lung Cancer and Lung Cancer Strategy at AstraZeneca.

Survival Surges with Dendritic Cell Vaccine in Pancreatic Cancer Phase 1/2 Study

Dendritic cell-based immunotherapy elicited favorable relapse-free survival (RFS) rates in a phase 1/2 study evaluating 28 patients with resected pancreatic cancer. The trial achieved its primary end point of 2-year RFS. In the trial, patients underwent pancreatectomy following standard-of-care treatment and dendritic cell-based immunotherapy. The results with this regimen were improved compared with those in the phase 3 PREOPANC trial (NCT05679583), which used preoperative chemotherapy before pancreatectomy but did not include dendritic cell-based immunotherapy.

“Advantages of [dendritic cell] vaccines over other recently used mRNA and long peptide vaccine approaches are multifactorial. [Dendritic cells] are the most professional antigen-presenting cells to stimulate both CD4 and CD8 tumor-reactive T cells. In line with our previous data, treatment was associated with minimal toxicity. This is critical, considering the morbidity associated with pancreatic resection and multiagent chemotherapeutic treatment,” according to the authors of the study published in the Journal of Clinical Oncology.

FDA Approves Convenient Blood Test For Colorectal Cancer Screening

A new, convenient blood test for colorectal cancer has been approved by the FDA. The Guardant Shield test can identify 83% of colorectal cancers according to study data published in The New England Journal of Medicine. The test is recommended for patients aged 45 and older who are at risk for colorectal cancers. Following a positive result using the Guardant Shield test, a colonoscopy should be conducted.

“Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a press release. “Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion.”

Pembrolizumab/Neoadjuvant Chemo Achieves Success in Unresectable HGSC

Pembrolizumab (Keytruda) plus neoadjuvant chemotherapy shows efficacy in patients with high-grade serous cancer (HGSC) that is not completely resectable, according to data from the phase 2 NeoPembOV study (NCT03275506). In the trial, investigators evaluated 91 patients with stage IIIC/IV HGSC who were treated with standard-of-care carboplatin and paclitaxel, with or without pembrolizumab (200 mg every 3 weeks). The primary endpoint was the complete resection rate at interval debulking surgery.

“Despite the relatively small sample size, this randomized phase 2 trial demonstrates that the integration of pembrolizumab into neoadjuvant therapy is feasible and promising, at least for some HGSCs. Deeper translational research (already envisaged when the trial was designed, including systematic collection of tumor biopsies and blood before and after [neoadjuvant chemotherapy]) will be important in interpreting the impact of the investigational regimen,” according to the authors of the study published in Nature Communications.

Lower Toxicity Highlights Success of THIO-Cemiplimab Combo in NSCLC

According to updated findings from the phase 2 THIO-101 study (NCT05208944), THIO (6-thio-2’-deoxyguanosine) plus the checkpoint inhibitor cemiplimab (Libtayo), continues to demonstrate tolerability and lower toxicity compared with standard-of-care treatment. The trial includes patients with advanced NSCLC who have previously failed 2 or more therapies. After at least 12 months on the treatment protocol, 6 of these patients have continued with the regimen.

“With current therapies, second-line treatment duration is usually around 3 to 4 months, and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for [patients with] advanced NSCLC faced with limited options,” said Vlad Vitoc, MD, chairman and chief executive officer of MAIA Biotechnology, in a press release.

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