This month’s Clinical Trials Conversation features 4 abstracts presented during ASCO 2024. These abstracts, curated by Maia and Manju, were selected due to their significance for the colorectal cancer community.

Highlighted Abstracts

1. Primary outcome analysis of the ORCHESTRA trial: A randomized phase III trial of additional tumor debulking to first-line palliative systemic therapy for patients with multiorgan metastatic colorectal cancer.

Abstract LBA3502

The trial, which ran from 2013 to 2023, recruited patients with extensive metastatic colorectal cancer (mCRC) with metastases in multiple organs to see if there was additional benefit when tumor debulking was added to standard of care systemic chemotherapy.

• Participants: 382 patients randomized to either tumor debulking + more chemotherapy or just more chemotherapy only. With tumor debulking in the experimental arm, at least 80% of tumors were treated, most with surgery, some with stereotactic body radiotherapy (SBRT).
• Results: The median overall survival: 30 months in the tumor debulking arm, 27.5 months in the chemotherapy only arm.
• Safety/Side Effects: 25% of those in the debulking group ended up with surgical complications, requiring intervention under general anesthesia.

The researchers concluded that even if there is still a role for debulking to treat symptoms in patients with extensive disease, the increasing use of local therapies in people with extensive disease needs further consideration because of the lack of benefit seen from this trial.

2. A phase 1/2 study of REGN7075 in combination with cemiplimab (cemi) in patients (pts) with advanced solid tumors: Efficacy and safety results.

Abstract 2503

This phase 1/2 study evaluates REGN7075 (a novel stimulatory bispecific antibody) combined with cemiplimab (a PD-1 checkpoint inhibitor) in patients with advanced solid tumors.

• Participants: 94 patients, including 65% with microsatellite stable (MSS) colorectal cancer (CRC).
• Results: Among 15 patients with microsatellite stable MSS CRC (without liver metastases), 20% experienced tumor shrinkage and 80% saw disease stabilization.
• Safety: No dose-limiting toxicities found, and most side effects were mild.

These early findings suggest REGN7075 can enhance immune responses in traditionally non-responsive tumors.

3. NEOPRISM-CRC: Neoadjuvant pembrolizumab stratified to tumour mutation burden for high risk stage 2 or stage 3 deficient-MMR/MSI-high colorectal cancer

Abstract LBA3504

The NEOPRISM-CRC looked at the safety and effectiveness of pembrolizumab (pembro; a PD-1 inhibitor) before surgery in patients with high-risk stage II or III mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) colorectal cancer after stratifying patients based on high or low tumor mutational burden (TMB) (TMB-Low, <10). This trial had extensive exploratory analysis including genomic and microbiome analysis, these results are not yet available.

• Participants: 32 patients with good performance status, TMB-high or medium got 3 cycles of pembro before surgery, TMB-low patients had surgery after 1 cycle of pembro.
• Results: 55% pathological complete response (pCR) in the intent-to-treat population, with no disease relapse observed during the short follow-up period.
• Safety: Two patients experienced grade 3 immune events; no grade 4 or 5 events reported.

Based on these results, the trial will expand to include more patients.

4. Surgery versus thermal ablation for small-size colorectal liver metastases (COLLISION): An international, multicenter, phase III randomized controlled trial

Abstract LBA3501

This randomized controlled phase III study compared surgical resection and thermal ablation for the treatment of small-size (≤3cm) resectable colorectal liver metastases (CRLM).

• Participants: 147 in the thermal ablation arm, 148 in the surgery arm.
• Results: Survival rates are similar between thermal ablation and surgical resection.
• Safety/Side Effects: Thermal ablation showed better safety profile compared to surgical resection. Adverse events, length of hospital stay, and local control were better with thermal ablation, which had no procedure-related deaths.

The results of the COLLISION trial may have important implications for the future management of patients with small-size resectable CRLM and increase interventional radiologists’ role in the clinical management of colorectal cancer.

These were our top 4 picks, but additional abstracts were covered during our 2024 ASCO Highlights webinar, presented by Dr. Dustin Deming, a gastrointestinal medical oncologist at the University of Wisconsin Carbone Cancer Center: CodeBreaK 300, MOUNTAINEER, ARC-9, TransMet and dostarlimab in locally advanced rectal cancer. You can watch the recorded webinar here.

If you are still searching for options, please visit Fight CRC’s Clinical Trial Finder, our Provider Finder, and our CRC Chatbot for additional resources and assistance. Stay informed and empowered with Fight CRC.

More Clinical Trial Conversations

• Starting the trials conversation in good time
• News about DNA-based, Noninvasive Tests for CRC Screening
• GI ASCO 2024 review
• ESMO 2023: News and Updates
• Clinical Trials for Prevention of Colon and Rectal Cancers