Home Blog June 2021: Clinical Trial Conversations June 2021: Clinical Trial Conversations June 24, 2021 • By Fight CRC Clinical Trial Conversations Share this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window) Share on Facebook Share on LinkedIn Share on Twitter Copy this URL Share via Email ASCO Annual Meeting 2021 Welcome to this month’s Clinical Trial Conversations series featuring Maia Walker, Lead Curator of the Fight Colorectal Cancer Trial Finder, and Manju George, Scientific Director of COLONTOWN! If you missed our first blog introducing Maia and Manju, be sure to check it out here. Every year, researchers, clinicians, pharmaceutical companies and patient advocates come together to attend the American Society of Clinical Oncology’s (ASCO) annual conference, the largest oncology conference in North America. In pre-pandemic times, thousands of individuals would gather from across the globe to discuss the latest in cancer research and brainstorm ways to continually advance science and care for the patient community. Like 2020, this year’s conference was held virtually, but that didn’t stop the momentum. Sessions were held, posters were presented, and advocates continued to engage with the research community. This year, Fight CRC also had an opportunity to contribute to the research! We published an abstract highlighting the landscape of COVID-19 vaccine uptake in the colorectal cancer community. We know our community has questions about the progress in science, what new research findings mean, and ultimately how this will affect the colon and rectal cancer community. This month’s Clinical Trials Conversation focuses on Maia and Manju’s top abstracts from ASCO. We know that science can be a lot to unpack and understand -- that’s why we’re hosting a conversation with Dr. Scott Kopetz on 6/30 at 3pm EST as he discusses the latest research findings such as the one’s highlighted here by Maia and Manju, in an easy to understand manner. Please tell us about the top three abstracts you think are important for the CRC community to be aware of. What impact could these findings have on future care for those facing colorectal cancer? Maia Three abstracts about research and clinical trials coming out from ASCO 2021 that are important for the patient community from my perspective include: Final overall survival for the phase III KN177 study: Pembrolizumab versus chemotherapy in microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (Abstract 3500) The awaited final results on overall survival data from the Keynote-177 trial were presented, which has significantly changed the standard of care for a percent of CRC patients (<4% of mCRC). For this particular group of patients, immunotherapy (pembrolizumab), as the first line of treatment in the metastatic setting, provides better progression-free survival and fewer side effects than chemotherapy. It also reduces mortality, even if that did not meet statistical significance, likely due to the high number of patients who were allowed to crossover from the chemo to anti-PD1/PD-L1 therapies arm of the trial. Novel CoupledCAR technology for treating colorectal cancer (Abstract 2528) From China comes the report about the use of CAR- T cells immunotherapy in patients with advanced colorectal cancer. In this trial, seven patients with colorectal cancer, for whom multiple rounds of chemotherapy and radiotherapy have failed, received autologous anti-GCC CoupledCAR-T in this trial. One of the patients achieved a complete response. “The CAR lentivirus vector consisted of a humanized CD19-specific single-chain variable fragment (scFv), a 4-1BB costimulatory domain, and a CD3f signaling domain.The lentivirus was produced by transfecting HEK-293T cells with CAR lentiviral vectors and viral packaging plasmids”. We definitely are looking forward to more information about this! LEAP-005: A phase 2 multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors—Results from the colorectal cancer cohort (Abstract 3564) The combination of lenvatinib and pembrolizumab (immunotherapy, anti PD-1) shows activity and is safe for patients with advanced MSS CRC cancer. Patients had an overall response rate of 22%, all of them, partial responses. The responders had PD-L1-positive tumors, as determined by pertinent tests. Based on these results, the enrollment in the colorectal cohort of this trial has expanded to 100 patients. Manju Survival and organ preservation according to clinical response after total neoadjuvant therapy in locally advanced rectal cancer patients: A secondary analysis from the organ preservation in rectal adenocarcinoma (OPRA) trial. Abstract 3509 Rectal cancer rates are rising in young people and “watch & wait (WW)” or Non-operative Management (NOM), is an attractive option for eligible individuals after total neoadjuvant therapy (TNT). This abstract talks about survival and organ preservation rates in locally advanced rectal cancer patients who had TNT, as part of a prospective, multi-center clinical trial. A 3-tier schema was used to stratify clinical response and group patients into 1) those with a complete clinical response (cCR) and so considered for WW, 2) those with an incomplete clinical response (iCR) and so recommended for surgery and 3) those with a near complete response (nCR) which was close to cCR, but not quite there yet. This grouping of responses was shown to have prognostic implications for organ preservation and disease-free survival in this group of patients. The results can be used for discussion about expected outcomes when talking to patients interested in not having surgery after TNT. A phase II study of capecitabine plus concomitant radiation therapy followed by durvalumab (MEDI4736) as preoperative treatment in rectal cancer: PANDORA study first-stage. Abstract 3607 In this study, addition of immunotherapy (Durvalumab) to long course chemo-radiation was tested in patients with locally advanced rectal cancer. Surgery was done 10-12 weeks after, and the treatment was considered to have worked if a pathologic complete response (pCR) was seen. Nineteen evaluable patients received 3 infusions of durvalumab after chemo-RT, and after a median 13 week interval, 18 underwent surgery. Of 18, 5 patients had pCR, which means that when the resected tissue was examined no tumor was found, showing that the treatment had been effective at killing all the tumor. Four out of 18 patients developed grade 3-4 adverse events. The second part of the trial is ongoing. Even though MMR status was tested, whether the patients who showed pCR were MSI-H was not disclosed. Considering that MSI-H is very rare in rectal cancer, a pCR rate of 5/18 after chemo-radiation and 3 infusions of durvalumab is intriguing. Results from the 2nd part of the trial may be of interest to young patients with locally advanced rectal cancer. Clinical trial information: NCT04083365 Serial circulating tumor DNA analysis to assess recurrence risk, benefit of adjuvant therapy, growth rate and early relapse detection in stage III colorectal cancer patients. Abstract 3540 In this study, serial ctDNA measurements were used to find recurrence based on ctDNA detection. They also compared CT scans and ctDNA measurements done at the same time, to see which one was better at detecting recurrence Stage III CRC patients treated with curative intent at Danish and Spanish hospitals in 2014-2019 were recruited (n = 166). Blood samples were collected before and immediately after surgery, and every three months for up to 3 years. A personalized ctDNA test (Signatera) was used in the study. Detection of ctDNA was a strong recurrence predictor after surgery, after adjuvant chemotherapy, and when measured serially after end of treatment. ctDNA either detected residual disease before the CT scan (lead-time 7.5 months) or at the same time. This study highlights many potential uses of ctDNA for clinical decision-making. The process of finding a clinical trial and enrolling can be daunting. Fight CRC and COLONTOWN are committed to providing the resources and tools to help the patient community identify the best option to improve quality of life, and improve access to care. Stay Tuned for More! Once a month, Maia and Manju will spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world! You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials. Learn More About Clinical Trials Want to know more, but not sure where to start? Let us help! Learn more Quick Links Clinical Trials Mini Magazine Clinical Trial Finder visit the trial finder Thank You to Our Sponsors Leave a Reply Cancel replyYour email address will not be published. Required fields are marked *Comment Name * Email * Website Save my name, email, and website in this browser for the next time I comment.