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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 the latest episode of Emerging Experts, Michael LaPelusa, MD, hematology and oncology fellow at MD Anderson Cancer Center, shares his insights, experiences, and passion for cancer research, particularly in the realm of gastrointestinal (GI) cancers.

LaPelusa delves into the importance of mentorship and education in shaping the next generation of oncologists. Drawing from his own experiences, he sheds light on the critical role of guidance and support when learning to navigate the ever changing and complex landscape of cancer care and research.

He also stresses the need for a strong network of mentors and sponsors to gain exposure to various diseases and therapies.

“I think oncology is changing so fast, and I am glad that this is the case, but so many new modalities of therapy and different diagnostic tools are making their way into practice…Making sure that people are exposed to a wide breadth of different types of diseases in their training, I think, is extremely important,” explains LaPelusa in an interview with Targeted Oncology

Currently, LaPelusa is conducting research on circulating tumor DNA in cancer prognosis and treatment response, with a focus on colorectal cancer. He shares some of the background of his work along with other studies in this space. He hopes that this kind of research will lead to better stratification of patients based on risk of recurrence and improved adjuvant therapy.

But the conversation does not stop there. LaPelusa also discusses promising targeted therapies for GI cancers, including antibody-drug conjugates and bispecific antibodies, and emphasizes the importance of early screening as the incidence of colorectal cancers in younger patients continues to rise.

“I think every person who treats patients with cancer is heartbroken when they see young people presenting to the clinic with advanced stage disease, so this is an area that urgently needs to be addressed,” adds LaPelusa.

In this episode of Emerging Experts, Michael LaPelusa, MD, shares his insights, experiences, and passion for cancer research, particularly in the realm of gastrointestinal cancers.

LaPelusa’s Journey in the Dynamic Field of GI Oncology 

In season 4, episode 1 of Targeted Talks, Benjamin L. Schlechter, MD, senior physician at Dana-Farber Cancer Institute and instructor in Medicine at Harvard Medical School, discuses new studies in the  gastrointestinal cancers space. Schlechter explains how these studies can inform future research.

First, in a phase 1a/1b study (NCT03860272) of botensilimab (AGEN1181) plus balstilimab (AGEN2034), promising clinical activity and durable responses were shown in patients with metastatic heavily pretreated patients with microsatellite stable (MSS) colorectal cancer (CRC). The findings were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). Schlecter explains that botensilimab is a first-in-class drug targeting the CTLA-4 protein receptor, and therefore offers something different than the anti-CTLA-4 therapies that are currently available.

“I don't think anyone expected things like this to work, because there have been so many failures in this space. I think it emphasizes that this is not just a CTLA-4 inhibitor, and not just a checkpoint inhibitor. There’s something fundamentally different about how this agent behaves. We see that in the efficacy profile and the toxicity profile. And I think it's easy to put this in the same basket as tremelimumab [Imjudo], or ipilimumab [Yervoy], and I don't think that's fair assessment. It's a next class of drug, and it really is its own thing,” Schlechter says.

In another early-phase study (TACTIC-02; NCT04727151), investigators are exploring the use of autologous T cells expressing T-cell antigen couple (TAC) that target HER2 in patients with solid tumors. Schlechter says that T-cell therapy is difficult in solid tumors, but if this study is successful, it will create opportunities for other targeted therapy studies in the future.

Schlechter says: “I think this is a really important beginning. If we can target HER2 safely and successfully, this really opens the door for a number of targets that right now are off limits. There are so many cancers right now that we know there's a target for, but we can't go after that target because there's so much targeting normal tissue that it will be dangerous to do so. This is both an important innovation in T-cell therapy and HER2. But this is also important innovation for cellular therapy in oncology because products like this would allow us to target far more things than we currently can with existing technology.”

Schlechter also discusses later-phase trials that appear to be practice-changing. The SUNLIGHT study (NCT04737187), for example, may have global implications for adding 

bevacizumab (Avastin) to the combination of trifluridine/tipiracil (Lonsurf)

 for the treatment of metastatic CRC. This strategy is already standard in the United States. In addition, adding liposomal irinotecan to 5-fluorouracil with leucovorin plus oxaliplatin (NALIRIFOX) may achieve better efficacy compared with standard treatment, as shown in the 

 in patients with pancreatic ductal adenocarcinoma.

1. El-Khoueiry AB, Fakih M, Gordon MS, et al. Results from a phase 1a/1b study of botensilimab (BOT), a novel innate/adaptive immune activator, plus balstilimab (BAL; anti-PD-1 antibody) in metastatic heavily pretreated microsatellite stable colorectal cancer (MSS CRC). 

. 2023; 41(suppl 4): LBA8. doi: 10.1200/JCO.2023.41.3_suppl.LBA8

2. Schlechter BL, Olson D, Sailbil S, et al. A phase I/II trial investigating the safety and efficacy of autologous TAC T cells targeting HER2 in relapsed or refractory solid tumors. 

. 2023;41(suppl 4): TPS816. doi: 10.1200/JCO.2023.41.4_suppl

In season 4, episode 1 of Targeted Talks, Benjamin L. Schlechter, MD, discuses new studies in the gastrointestinal cancers space.

Unpacking the Latest Research in Gastrointestinal 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

The combination of pembrolizumab, trastuzumab, and chemotherapy is now approved in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

FDA Grants Standard Approval to Pembrolizumab Plus Trastuzumab/Chemo for HER2+, PD-L1+ Gastric Cancer

The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line treatment.

FDA Grants Orphan Drug Designation to HLX22 for Gastric Cancer Treatment

A phase 3 trial plans to evaluate Pro-ocular for the treatment of patients with ocular graft-vs-host disease.

FDA Backs Phase 3 Trial of Pro-ocular for Ocular GVHD Treatment

Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.

Kato Breaks Down FDA Approval of Tislelizumab in Esophageal Cancer 

The TEDOPaM trial evaluating a novel maintenance therapy approach for advanced/metastatic pancreatic ductal adenocarcinoma has met its primary end point. 

Phase 2 Trial of OSE2101 in Advanced PDAC Meets Primary End Point 

Experts Discuss Tislelizumab’s FDA Approval in Esophageal Cancer 

FDA approved the combination of tislelizumab-jsg

 (Tevimbra) and platinum-containing chemotherapy as a frontline treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) with a tumor PD-L1 expression of 1 or higher on March 4, 2025.This approval was supported by data from the phase 3 RATIONALE-306 trial (NCT03783442).

, Ken Kato, MD, PhD, chief of the department of head and neck, and esophageal medical oncology and gastrointestinal medical oncology at the National Cancer Center Hospital in Tokyo, Japan, and Harry H. Yoon, MD, MHS, professor of oncology, enterprise co-leader, gastrointestinal and hepatobiliary/pancreatic cancer research program, enterprise vice-chair, gastrointestinal cancer disease group, associate chair for translational research, department of oncology at the Mayo Clinic Comprehensive Cancer Center, delved into this FDA approval and what it means for oncologists across the world.

 The FDA approval is for tislelizumab, which is an anti-PD1 antibody, and it is the first FDA approval for this agent in this indication, which is previously untreated patients with advanced squamous cell cancer of tislelizumab in combination with cytotoxic chemotherapy. So, it gives another optionfor patients in various parts of the world.

Tislelizumab is an anti-PD-1 antibody made in China. The trial evaluated tislelizumab in combination with platinum-containing chemotherapy regimens. The RATIONALE-306 trial aimed to validatethe additive effect of tislelizumab to baseline chemotherapy and its role in the first-line treatment of esophageal squamous cell carcinoma.

RATIONALE-306 was a global phase 3 trial, and it tested whether adding tislelizumab to standard chemotherapy could improve overall survival. And it was a placebo-controlled study, and the trial met its primary end point, which is overall survival. And the median survival was approximately 17 months with tislelizumab and about 10 months in placebo.

[The primary result of RATIONALE-306 showed a hazard ratio of 0.66] for the entire population, regardless of PD-L1 positivity. The median survival time for the chemotherapy plus tislelizumab arm was 17.2 months, compared with 10.6 months for chemotherapy alone. For the population with a PD-L1 CPS of 10% or more, the hazard ratio improved to 0.62. Even in the population with a PD-L1 CPS of less than 10%, the hazard ratio was 0.77, which is still favorable compared to the chemotherapy-alone arm. This led to the FDA approval of tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of ESCC.

And one of the things that was notable about the results was that 3years later, about 15% of patients in the tislelizumab arm remained free of progression. So, as a durable response, and it is a really remarkable outcome in patients with advanced esophageal squamous cancer.

Tevimbra approved in US for first-line treatment of advanced esophageal squamous cell carcinoma in combination with chemotherapy. News release. BeiGene, Ltd. March 4, 2025. Accessed March 11, 2025. https://tinyurl.com/bdzy9e59

Xu J, Kato K, Raymond E, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023;24(5):483-495. doi:10.1016/S1470-2045(23)00108-0

Videos

Ken Kato, MD, PhD, and Harry H. Yoon, MD, MHS, discussed the recent FDA approval of tislelizumab in the first line for patients with esophageal squamous cell carcinoma. 

News

Next Steps for Evaluating 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, discusses the next steps for the clinical development of the combination of balstilimab with botensilimab for the treatment of patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases.

This combination is currently being evaluated in the phase 2 trial (NCT05608044). Findings were presented at the 

The next step is to have a confirmatory trial to prove that this combination is better than best supportive care. Of interest is the fact that we did have a control arm in the study that we reported on, and that was the standard arm of trifluridine or regorafenib, but only 21 patients enrolled in that arm, and partly because some patients who were randomized to this arm actually dropped off before receiving treatment. In the 21 patients who received trifluridine in our trial, there were no responses. As expected, the response rate for trifluridine as monotherapy is historically about 2% to 3%, and regorafenib is only a 1% response rate, so those agents do not really result in major shrinkage.

 We do believe that if we go to a phase 3 clinical trial, it will hopefully be positive, but it will be required by regulatory bodies, and the goal is to proceed with a randomized phase 3 clinical trial with an overall survival end point to confirm beyond doubt the benefits that we see in our phase 2.

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



Marwan G. Fakih, MD, discusses the next steps for the clinical development of the balstilimab plus botensilimab in microsatellite stable metastatic colorectal cancer without liver metastases.


Hijioka Discusses STARTER-NET: Everolimus Plus Lanreotide in GEP-NETs

Susumu Hijioka, MD, from the Department of Hepatobiliary and Pancreatic Oncology at the National Cancer Center, discusses the key takeaways from the phase 3 STARTER-NET trial (jRCT1031200023) evaluating the combination of everolimus (Afinitor) with lanreotide (Somatuline) when used for the first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

According to findings presented at a press briefing prior to the 2025 Gastrointestinal Cancers Symposium, everolimus plus lanreotide led to a significant improvement in progression-free survival (PFS) when compared with everolimus monotherapy as a first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

The median PFS was 29.7 months (95% CI, 20.5-not evaluable [NE]) in the everolimus plus lanreotide arm vs 11.5 months (95% CI, 9.0-19.8) in the everolimus monotherapy arm, with a stratified HR of 0.38 (99.91% CI, 0.15-0.96; one-sided 

 = .00017). The 1-year survival in the everolimus plus lanreotide group was 96.2% (range, 88.8%-98.8%) in the everolimus plus lanreotide group and 97.0% (range, 88.4%-99.2%) in the everolimus group, and the HR for overall survival was 0.74 (95% CI, 0.25-2.24).

For objective response rate (ORR), the ORR was 23.0% (95% CI, 14.6%-33.3%) in the everolimus plus lanreotide group (n = 87) and 8.3% (95% CI, 3.4%-16.4%) in the everolimus group (

 =.011). Twenty-three percent and 8.3% of patients, respectively, had partial responses (PRs), 69.0% and 76.2% had stable disease (SD), 2.3% and 10.7% had progressive disease, and 5.7% and 4.8% were NE. The disease control rate (DCR) was 92.0% (95% CI, 84.1%-96.7%) and 84.5% (95% CI, 75.0%-91.5%), respectively (

Unresectable or recurrent neuroendocrine tumors have a relatively good prognosis. So, that is why I agree. I recommend to use…for the indolent patient, indolent head and neck patient. However, the more aggressive patient, our study of the combination therapy [led to a] higher progression-free survival, so we recommend that you use a combination therapy for patients with prognostic factors.

1. Susumu H, Honma Y, Machida N, et al. A phase III study of combination therapy with everolimus plus lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (JCOG1901, STARTER-NET).

2025;43(suppl 4):652. doi:10.1200/JCO.2025.43.4_suppl.652

Susumu Hijioka, MD, discusses the key takeaways from the phase 3 STARTER-NET trial evaluating the combination of everolimus with lanreotide when used for the first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

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