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Clinical

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

Jeneth Aquino, DNP, FNP-BC; Beth Sandy, MSN, CRNP, FAPO; Allison M. Walker, ACNP, MSN, MSW, BS

Differentiating Adverse Events for Antibody-Drug Conjugates Across Solid Tumor Management

Benjamin P. Levy, MD; John O. Mascarenhas, MD; Tiffany A. Traina, MD, FASCO; Cathy Eng, MD, FACP, FASCO; John P. Leonard, MD

 42nd Annual CFS: Chemotherapy Foundation Symposium®: Innovative Cancer Therapy for Tomorrow

In season 4, episode 18 of Targeted Talks, Arvind Dasari, MD, MS, associate professor in the Department of Gastrointestinal Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas, dives into the recent approval of fruquintinib for patients with metastatic colorectal cancer (mCRC).

On November 8, 2023, the 

 (HMPL-013) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if 

 wild-type and medically appropriate, an anti-EGFR therapy.

Dasari explains that fruquintinib is a selective inhibitor of VEGFR-1, -2, and -3. Previously, the agent has inhibited the migration, proliferation, and survival of endothelial cells and also inhibited microvessel formation, tumor cell proliferation, and tumor cell death.

 (NCT04322539) support this regulatory decision. In the phase 3 study, fruquintinib led to a reduction in the risk of death by 34% when given to patients with refractory mCRC. The median overall survival (OS) seen with fruquintinib was 7.4 months compared with 4.8 months with best supportive care in the study. These data represent a significant improvement in OS (HR, 0.66; 95% CI, 0.55-0.80; 

In terms of safety, Dasari highlights some of the adverse events observed in the study, including fatigue, hand-foot syndrome, and issues with liver function tests, but notes that they were rare, reflecting the good toxicity profile of the agent.

With this new approval, Dasari looks forward to the future development of fruquintinib beyond its current indication. He hopes to see the agent move into earlier lines of therapy and given in combination with other drugs to build upon its efficacy.

Takeda receives U.S. FDA approval of FRUZAQLA™ (fruquintinib) for previously treated metastatic colorectal cancer. Takeda. News release. November 8, 2023. Accessed November 8, 2023. https://tinyurl.com/2rkwetvu

Dasati NA, Lonardi S, Garcia-Carbonero R, et al. LBA25 - FRESCO-2: A global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann oncol. 2022;33 (suppl_7): S808-S869. doi:10.1016/annonc/annonc1089

Dasari A, Lonardi S, Garcia-Carbonero R, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomized, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9



In season 4, episode 18 of Targeted Talks, Arvind Dasari, MD, MS, dives into the recent approval of fruquintinib for patients with metastatic colorectal cancer.


Behind the FDA Approval of Fruquintinib for Previously Treated mCRC

In season 2, episode 6 of Targeted Talks, Dr. Michael J. Overman, a professor in the Department of Gastrointestinal Medical Oncology, at the University of Texas MD Anderson Cancer Center, joins us for a special discussion around rare genomic alterations in colorectal cancer.

First, Overman explains that there has been recent success in looking at subsets of colon cancer based on genomic alterations. Gene fusions, polymerase epsilon mutation, 

 mutations were all among the rare aerations he discusses. Although all of these alterations are rare and often leave a treatment gap for patients with CRC, there are some that are more difficult to treat than others, Overman says, like the 

Testing for rare genomic alterations in CRC has also made progress recently. The historical testing guidelines required testing for 

 mutations to identify patients who could benefit from anti-EGFR therapies. Today, the guidelines also mandate testing for 

The future of treatment for patients with CRC harboring rare genomic alterations is hopeful, considering the number of ongoing clinical trials. Overman says that there are many novel combination therapies. He also explains that research around MRD and microsatellite instability is the current focus for CRC, and PD-1/PD-1 inhibitors, as well as antibody-drug conjugates, are being explored for the treatment of these patients.

In season 2, episode 6 of Targeted Talks, Dr. Michael J. Overman, joins Targeted Oncology for a special discussion around rare genomic alterations in colorectal cancer

Special Episode: Insight on Targeting Rare Genomic Alterations in Colorectal Cancers

In season 2, episode 2 of Targeted Talks, Cathy Eng, MD, the David H. Johnson Chair in Surgical and Medical Oncology; professor of medicine, hematology and oncology; co-director, GI Oncology at Vanderbilt-Ingram Cancer Center, speaks with Benjamin Weinberg, MD, associate professor of medicine, Division of Hematology and Oncology, in the Lombardi Comprehensive Cancer Center at Georgetown University, about the gut microbiome, and how the presence of certain microbiota impact the onset and intensity of disease as well as the potential response to certain treatments.

In recent years, the increasing number of 

young adults developing colorectal cancer

 has been believed to be closely linked with the gut microbiome. Several studies have examined this onset of disease and suggested that diet and obesity may play a role. Still, there is little known about how the gut microbiome may impact average-aged patients and the older patient population.

Other ongoing questions in the space include how to utilize information obtained from 

gut microbiome research in colorectal cancer

 to diagnose, treat, and monitor disease.

In season 2, episode 2 of Targeted Talks, Cathy Eng, MD, speaks with Benjamin Weinberg, MD, about the gut microbiome, and how the presence of certain microbiota impact the onset and intensity of disease as well as the potential response to certain treatments.

The Impact of the Gut Microbiome in Young Patients With Colorectal Cancer

Marwan G. Fakih, MD, discussed the implications of the findings from the phase 2 study for patients with microsatellite stable metastatic colorectal cancer without liver metastases.

Balstilimab Plus Botensilimab Shows Better Response in MSS mCRC 

Bevacizumab's survival benefits in CRC patients persist for about 2 years after starting treatment.

Bevacizumab Benefits in CRC Persist for Two Years After Initiation

Patients with BRAF V600E-mutant metastatic colorectal cancer experienced poor clinical outcomes with systemic therapy, according to real-world data.

Poor Outcomes Seen in BRAF V600E-Mutant mCRC With Systemic Therapy

A "watch and wait" strategy after total neoadjuvant therapy showed similar outcomes and safety to total mesorectal in stage II/III rectal cancer.

Watch and Wait Post-TNT Safe with Similar Outcomes to TME in Rectal Cancer

Early palliative care reduces invasive interventions and enhances comfort at EOL for CRC patients, according to real-world study results.

Early Palliative Care Improves EOL Comfort in Colorectal Cancer

Fakih Discusses Phase 2 Trial of Balstilimab Plus Botensilimab in MSS mCRC

Marwan G. Fakih, MD, professor in the Department of Medical Oncology & Therapeutics Research, co-directs the Gastrointestinal Cancer Program at City of Hope Comprehensive Cancer Center, explains the implications of the findings from the phase 2 trial (NCT05608044) of balstilimab plus botensilimab for the treatment of patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases.

The primary end point is overall response rate, and I think we showed activity. Interestingly, this was in line with the data and results that were published in 

 in the large phase 1 trial with this combination, where the overall response rate was 23%, so I think it is confirmatory that the combination is effective.

 The other secondary end points were progression-free survival and overall survival. Those results are still being monitored and followed. They have not fully matured, but we did report that in our responders on this study, 70% continue to be without evidence of progression, and the median duration of response has not been met, indicating that the treatment is not only effective in shrinking the tumors and maintaining disease stability but that, in those patients who have a good response, it appears to be durable.

Of note, the disease control rate on the combination arms was approximately 54% to 55% of patients, meaning more than half of the patients did benefit from the combination arm.

Fakih M, Segal NH, Schlechter BL, et al. Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal cancer with no liver metastases (MSS mCRC NLM). 

. 2025;43(suppl 4):23. doi:10.1200/JCO.2025.43.4_suppl.23

Videos

Marwan G. Fakih, MD, explains the implications of the findings from the phase 2 trial of balstilimab plus botensilimab for the treatment of patients with microsatellite stable metastatic colorectal cancer without liver metastases. 


News

Preliminary Data Show the Potential of Balstilimab Plus Botensilimab in MSS mCRC

Marwan G. Fakih, MD, professor in the Department of Medical Oncology & Therapeutics Research, co-directs the Gastrointestinal Cancer Program at City of Hope Comprehensive Cancer Center, provides an overview of the study design, rationale, and findings from a phase 2 trial (NCT05608044) which evaluated balstilimab with botensilimab for the treatment of patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases. Fakih presented on the trial at the 

We presented the results of a randomized phase 2 clinical trial of botensilimab and balstilimab in different combinations, either monotherapy or in combination, and we compared that to a standard-of-care arm. This is a 5-arm trial, multicenter, and the main purpose of this study was to answer the question: what does balstilimab, which is a PD-1 inhibitor, add to botensilimab, which is a CTLA-4 inhibitor?

Number 2, we also tried to answer the question, is there an optimal dose with botensilimab in that? It is a randomized phase 2 clinical trial with 5 arms, and the study was in patients with metastatic colorectal cancer who have microsatellite stability and have progressed on prior standard chemotherapy.

 The main endpoint of this study was overall response rate. What we found is that botensilimab plus balstilimab was effective in substantially reducing the tumor burden in patients. The overall response rate was 19% in patients who received both botensilimab/balstilimab with botensilimab at 75 mg every 6 weeks for up to 4 doses, and balstilimab at 40 [intravenously] every 2 weeks for up to 2 years. This was the highest response rate in the 5 arms that we tested.

 We also found that the combination at the higher dose of botensilimab, 150 mg, was associated with responses, but that was a little lower at 8%. Interestingly, the disease control rate, which is the combination of objective response and stable disease, was similar for the combination arm. The main result is that the highest response rate is with the lower dose of botensilimab 75 mg in combination with balstilimab, and we also found that when we gave botensilimab alone at the same dose level of 75 mg, we did not see objective responses, which confirms the contribution of both agents, meaning that you do need both agents together to get the best outcome.

Marwan G. Fakih, MD, provides an overview of the study design, rationale, and findings from a phase 2 trial of balstilimab with botensilimab for the treatment of patients with microsatellite stable metastatic colorectal cancer without liver metastases.

Innovative PET Imaging With Cu 64 Anti-CEA in Advanced Rectal Cancer

Jeffrey Wong, MD, a professor of radiation oncology at City of Hope Medical Center, discusses findings on the use of Cu 64 anti-CEA M5A as a PET imaging agent for advanced rectal cancer presented at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting.

 The study was designed first for patients with locally advanced rectal cancer, most of whom did not have any known sites of metastatic disease. This with the patients were scanned prior to therapy. Therapy is, for most patients with local locally advanced rectal cancer, chemotherapy, radiation therapy, and then surgery. This study was designed to do a radiolabeled or Cu 64 anti-CEA PET scan prior to radiation therapy and chemotherapy and after radiation therapy, but prior to surgery. The objectives were to determine how this agent could identify disease before therapy, and could it also determine tumor response after therapy?

The first scan wanted to determine whether it could identify disease. This is a pilot study, but in the number of patients we studied, all of them showed targeting of the antibody to known sites of disease patients. There were also patients where there was disease detected outside of the pelvic region. That could impact radiation field coverage, or even impact on whether a patient is appropriate for radiation therapy. That is another objective, and that was another finding.

The third finding was that we found that after radiation therapy is done, but prior to surgery, there were patients that had a positive PET scan before therapy, but then a negative PET scan after therapy, and they went on to surgery or biopsy, and that confirmed that there was absence of a tumor when the PET scan became negative. Although more work needs to be done, the potential is that this scan, especially performed prior to surgery, might help select patients who are appropriate to just continue to watch and avoid the surgery. Again, it is a bit early to reach that conclusion, but this trial was to see if there is any potential for this particular agent to do that.

Jeffrey Wong, MD, discusses findings on the use of Cu 64 anti-CEA M5A as a PET imaging agent for advanced rectal cancer presented at the 2024 American Society for Radiation Oncology Annual Meeting.

Conference News

Dostarlimab: Game Changer in Rectal Cancer Treatment?

Mark A. Lewis, MD, director of gastrointestinal oncology at Intermountain Health, discusses the exciting progress of dostarlimab (Jemperli), an immunotherapy drug, in treating rectal cancer.

updated data presented at the 2024 American Society of Clinical Oncology Annual Meeting

, showed a remarkable 100% complete response rate in patients with mismatch repair–deficient colorectal cancer. This, Lewis explains, could potentially eliminate the need for chemotherapy, radiation, and surgery in this patient population.

Lewis emphasizes the importance of wider adoption of this approach. However, concerns exist about whether the effectiveness of dostarlimab is unique or if other similar agents would work.

Additionally, Lewis highlights the need for more widespread testing for the specific mutation to ensure all eligible patients benefit. Overall, dostarlimab presents a promising new direction in treating rectal cancer, but further research and wider testing to maximize its potential is still needed.

 So, dostarlimab is a fascinating drug. Of course, it is 1 of many immunotherapies available now in GI cancer. Specifically, it is a PD-1 inhibitor. And I have to say, although we're talking about ASCO 2024, arguably dostarlimab was kind of the belle of the ball 2 years ago at ASCO 2022 when the Memorial Sloan Kettering group led by Andrea Cercek, MD, first announced really remarkable results. What they announced at that meeting was the in locally advanced mismatch repair–deficient rectal cancer, they were seeing in their first dozen or so patients complete clinical responses to upfront immunotherapy. And by upfront, I mean was originally given with neoadjuvant intent. But neoadjuvant implies that surgery is going to follow. And of course, in rectal cancer for years and decades, our paradigm has been one of trimodality therapy. So typically radiation and chemotherapy given preoperatively and then surgery.

For a long time, we have been asking the question, well, what if chemo and radiation are enough? Does that actually change the paradigm from TNT, total neoadjuvant therapy, to TDT, total definitive therapy? Because again, adjuvant or neoadjuvant, those are moot points if there is no surgery. But this went one better than that MSKCC study because they showed again, 12 out of 12, 100% complete clinical responses. If memory serves, I think it was on the front page of The New York Times, the same day as plenary in 2022. I know for a fact that my friends and family who are not in medicine knew about it roughly the same time I did. It was a big news story. Dr. Cercek herself has recently been recognized, I think rightly so, as one of the top 100 people in healthcare by Time Magazine.

 Regardless, the point of this meeting was an update now, 2 years on, not just for those original 12 or so enrollees, but for more enrollees on their trial. Again, the same criteria, mismatch repair–deficient locally advanced rectal cancer getting to dostarlimab for up to 6 months. Still 100%. It is truly remarkable, a 100% clinical complete response rate. What we now have with time is 20 of those patients have what they're calling a sustained clinical response of longer than a year. So this is amazing. This is the new era of not just neoadjuvant, but definitive management in rectal cancer. It doesn't require chemotherapy, doesn't require radiation, doesn't require surgery, which is absolutely amazing.

 I think that the big question is, is this really special to dostarlimab, not denigrating the investigators would quote any anti-PD-1 agent do in this setting. I think a lot of us wonder about that. And then secondly, I think this just raises the importance of making sure that all the patients who would be eligible for this approach are tested. We are now absolutely in the era where biomarker testing is as important in colorectal cancer as say it is in breast cancer. The reason I use breast cancer as an analogy is that no oncologist I know would ever dream or dare of treating breast cancer without at least trying to establish the ER, PR, and HER2 receptor status. The entire management of breast cancer is predicated on knowing receptors.

 But we are at that point now, and have been in colorectal cancer, and the reason I have reservations about the generalizability of this study is I know from studying real-world practice, only about 2 thirds of patients with colorectal cancer are even getting tested for mismatch repair deficiency or microsatellite instability. To me, that means we are missing a full third of patients who could benefit, which is just completely unacceptable. We need to change the paradigm, we need to view breast cancer as sort of the high watermark, and then we need to bring the other tumor types, especially in GI up to that level. But do not get me wrong. These are all just my minor critiques. I think this is an incredibly exciting and more mature dataset that the Sloan Kettering investigators have given us.

Mark A. Lewis, MD, discusses the exciting progress of dostarlimab in treating rectal cancer. 


Daniel H. Ahn, DO, discusses treatment with regorafenib for patients with advanced CRC.

Regorafenib Continues to Benefit Patients With Advanced CRC

Daniel H. Ahn, DO, discusses how regorafenib continues to benefit patients with advanced colorectal cancer as researchers look to modify treatment strategies with the therapy. 

Colorectal Cancer

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