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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

T-DM1 was tolerable in HER2-positive biliary tract adenocarcinoma but did not significantly improve progression-free survival.

T-DM1 Shows Tolerability in HER2+ Biliary Tract Adenocarcinoma

Dose reductions of liposomal irinotecan and oxaliplatin did not compromise overall survival in patients with metastatic PDAC on NALIRIFOX.

Dose Reductions of Liposomal Irinotecan, Oxaliplatin Don’t Affect OS in Metastatic PDAC

NALRIFOX showed numerically better overall survival vs FOLFIRINOX as frontline treatment in PDAC, per real-world analysis results.

Real-World Data Shows NALRIFOX Boosts OS vs FOLFIRINOX in PDAC 

Certepetide plus chemotherapy showed signs of efficacy but failed to improve progression-free survival in metastatic PDAC in the ASCEND trial.

ASCEND Trial of Certepetide Plus Chemo Fails to Improve PFS in Metastatic PDAC

Adding CRT to chemotherapy did not improve RFS in resected gallbladder cancer in the phase 3 ACCELERATE trial.

CRT Adds No RFS Benefit Over Chemotherapy in Resected Gallbladder Cancer

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

Videos

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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Exploring Zoldonrasib, Pan-RAS Inhibitors, and Future KRAS Therapies

Alexander I. Spira, MD, PhD, FACP, co-director of Virginia Cancer Specialists Research Institute, director of the Thoracic and Phase I Program, and clinical assistant professor at Johns Hopkins School of Medicine, discusses the next steps in the clinical development of zoldonrasib (RMC-9805) for patients with 

 G12D pancreatic ductal adenocarcinoma based on preliminary findings presented at the 2025 Gastrointestinal Cancers Symposium.

 This is where it gets complicated. RMC-9805 clearly has single-agent activity. There is a pan RAS inhibitor called RMC-6236, which is already in development and already [has begun] in a randomized, phase 3 study in the second-line setting. The questions are: is an allele-specific inhibitor with fewer adverse events going to be better in terms of both efficacy and tolerability? And how do you study those differences? These are some of the questions being addressed in the second-line setting. We all believe that, because this drug is so well tolerated, it could also be combined with chemotherapy in the frontline setting.

And of course, while this is ASCO GI, there is also data in other tumor types. 

 G12D makes up about 4% of lung cancer cases. We are seeing activity there, and there are patients enrolled in this study with other tumor types as well. So, there are a lot of different pathways to consider for drug development, including pan-RAS inhibitors.

 Can you combine a pan-RAS inhibitor with an allele-specific inhibitor? We also know that many resistance mutations that develop after KRAS G12D therapy, based on the KRAS G12C data published several years ago, are other 

 mutations. So, can combination therapies prevent or delay that resistance? There are lots of good questions and many exciting [possibilities for future research].

Alexander I. Spira, MD, PhD, FACP, discusses the next steps in the clinical development of zoldonrasib for patients with KRAS G12D pancreatic ductal adenocarcinoma based on preliminary findings.

Spira on ctDNA in KRAS G12D Pancreatic Cancer and Zoldonrasib

Alexander I. Spira, MD, PhD, FACP, co-director of Virginia Cancer Specialists Research Institute, director of the Thoracic and Phase I Program, and clinical assistant professor at Johns Hopkins School of Medicine, discusses the clinical implications of circulating tumor DNA (ctDNA) findings presented at the 2025 Gastrointestinal Cancers Symposium for treatment decisions and monitoring in patients with 

 G12D pancreatic ductal adenocarcinoma treated with zoldonrasib (RMC-9805).

He then discusses how this information might guide treatment strategies in the real-world setting.

 ctDNA is one of those things that we are really learning a lot more about. Of course, we work with it for regulatory reasons. Response rate is the number one thing we look at, and the number two thing we look at, of course, all the time. However, we also know that in some of these patients, especially in the heavily pretreated population, response rate does not always correlate with clinical benefit rate. That is why we look at overall survival and progression-free survival [PFS] as well.

 What we found here was some fairly impressive numbers. If you look at what we call variant allele frequency, or VAF, 39% of patients had a 100% decrease in their 

 G12C or G12D VAF, and 86% of patients had at least a 50% decline in that number. That tells us a couple of things: it tells us that patients who are responding—patients who are responding but not showing it on imaging—are also doing very well.

 And that goes into the clinical benefit rate, and we hope into the overall survival rate. We know it’s a nice way of getting an idea of what’s going on before you get those overall survival signals, as well as early on, even before you get a scan. Can you see some kind of benefit there? So, this tells us we are getting benefit from the drug in multiple different ways, which can lead us to larger studies, phase 3 studies, and likely improvements in overall survival and PFS. We hope, of course, as we get to those study designs.

Alexander I. Spira, MD, PhD, FACP, discusses the clinical implications of ctDNA for treatment decisions and monitoring in patients with KRAS G12D pancreatic ductal adenocarcinoma treated with zoldonrasib.


Non-Invasive Biomarkers: Key to Better Pancreatic Cancer Outcomes

Ajay Goel, PhD, AGAF, professor and chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope, discusses how, given the limitations of current screening methods for pancreatic cancer, the development and validation of novel non-invasive biomarkers can improve early detection and ultimately impact patient outcomes for patients.


Goel presented on the topic of noninvasive biomarkers for the early detection of pancreatic cancer during the 

Ajay Goel, PhD, AGAF, discusses how the development and validation of novel non-invasive biomarkers can improve early detection and ultimately impact patient outcomes for patients.


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