Onco-Summaries: Daily Oncology Updates at a Glance

25/08/2025

Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref)

The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling.

• Dan Edelstein, Vice President and General Manager, Haystack Oncology: "We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumors, building on this first designation for an early-stage colorectal cancer. Our goal is to deliver highly accurate, personalized monitoring of treatment response and recurrence to more patients, both in clinical care and in pharmaceutical trials, and this Breakthrough Designation brings us closer to our goal."

In the Ph2 VERSATILE-002 trial, PDS Bio's Versamune HPV + pembro demonstrated improved mOS of 39.3 mos in first-line SCCHN (Ref)

PDS Biotech reported the final topline survival results from its Ph2 VERSATILE-002 trial of Versamune HPV (liposomal HPV-16 E6/E7 multi-peptide vaccine) + pembrolizumab as a first-line Tx of HPV16+ve, PD-L1 CPS ≥1, R/M SCCHN. 

• The updated mOS was 39.3 mos (95% CI: 23.9 mos - NE)

  
  

• Kirk Shepard, CMO, PDS Biotech: “We believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers. We believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients. We look forward to publishing the full data set for this trial later this year.”

  
  

• Frank Bedu-Addo, President and CEO, PDS Biotech: “With these results, PDS Biotech is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated, and no patients discontinued the trial due to treatment-related adverse events.”