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Dr. Rohan Garje is a medical oncologist and the chief of genitourinary medical oncology at Miami Cancer Institute in Florida.

Primary urothelial cancer has variable histologies, making its treatment complex, leading to varied outcomes with high rates of recurrence in patients.

An Expert Explains The Risk and Outcomes of Primary Urothelial Cancer Treatment

Among patients with previously untreated, advanced renal cell carcinoma (RCC), treatment with Opdivo (nivolumab) plus Cabometyx (cabozantinib) resulted in long-term efficacy and manageable safety versus treatment with the standard of care, Sutent (sunitinib), study results have shown.

Final follow-up results from the phase 3 

 were presented at the 2025 ASCO Genitourinary Cancer Symposium.

At the median follow up of 67.6 months for the intention to treat population, the median progression-free survival (PFS) was 16.4 months for patients who received Opdivo/CabometyxCabometyx and 8.3 months for those who received Sutent; median overall survival (OS) was 46.5 months versus 35.5 months, respectively, and median duration of response (DOR) was 22 months versus 15.2 months.

The overall response rate (ORR) was 55.7% versus 27.4% for patients in the Opdivo versus Sutent arms, respectively. Of patients who received Opdivo/Cabometyx, 20.1% experienced a partial response (PR) with 60% or more tumor reduction, and 21.7% received a PR with less than 60% tumor reduction. In the Opdivo/Cabometyx arm versus the Sutent arm, complete responses were observed in 45 and 15 patients, PRs in 135 and 75, stable disease in 104 and 136, progressive disease in 21 and 47 and unknown in 18 and 55.

“Long term efficacy benefit was observed with [Opdivo plus Cabometyx] over [Sutent] in these final results from the CheckMate 9ER trial, with a median of 67.6 months follow-up,” presenting author Dr. Robert J. Motzer, section head of Kidney Cancer in Genitourinary Oncology Service and Jack and Dorothy Byrne Chair in Clinical Oncology at Memorial Sloan Kettering Cancer Center, and coauthors, wrote in the presentation. “The results continue to support [Opdivo plus Cabometyx] as a standard of care for previously untreated advanced RCC.”

A total of 651 patients were enrolled in the trial and randomly assigned to receive 240 mg of intravenous Opdivo every two weeks plus 40 mg of oral Cabometyx daily (323 patients) or 50 mg of oral Sutent daily on four weeks on, two weeks off schedule (328 patients). Eligible patients had previously untreated advanced or metastatic RCC with a clear cell component who were in any International Metastatic RCC Database Consortium (IMDC) risk group.

Of patients in the IMDC favorable risk group, the median PFS in the Opdivo/Cabometyx group (74 patients) was 21.4 months versus 12.8 months in the Sutent group (72 patients); median OS was 53.7 months versus 58.9 months, respectively, and ORR was 66.2% versus 43.1%.

In the IMDC intermediate or poor risk group, the median PFS in the Opdivo/Cabometyx group (249 patients) was 15.4 months versus 7.1 months in the Sutent group (256 patients); median OS was 43.9 months versus 29.2 months, respectively, and ORR was 52.6% versus 23%.

Patients with liver metastases had a median PFS was 10.9 months in the Opdivo/Cabometyx group (73 patients) and 6.2 months in the Sutent group (56 patients); median OS was 37.6 months and 22.1 months, respectively; ORR was 52.1% and 21.4%.

Of patients with bone metastases, the median PFS was 13.8 months in the Opdivo/Cabometyx group (79 patients) and 5.3 months in the Sutent group (75 patients); median OS was 34.8 months and 20.7 months, respectively; ORR was 49.4% and 9.3%.

Those with lung metastases demonstrated a median PFS was 16.4 months in the Opdivo/Cabometyx group (241 patients) and 8.3 months in the Sutent group (251 patients); median OS was 47.5 months and 32.4 months, respectively; ORR was 57.3% and 27.9%.

Additionally, 93% of patients in the Opdivo/Cabometyx group and 95% in the Sutent group discontinued treatment; 43% and 55%, respectively, received subsequent systemic therapies; 26% and 31% received two or more subsequent systemic therapies; and the most common was any VEGFR inhibitor (79%) in the Opdivo/Cabometyx group and any PD-L1 inhibitor (81%) in the Sutent group.

The median duration of therapy was 21.8 months in the Opdivo/Cabometyx group and 8.9 months in the Sutent group; 62% and 55% of patients had at least one dose reduction; and the median time to first dose reduction was 4.1 months and two months.

Regarding safety, common treatment-related side effects of any grade occurred in 98% of patients in the Opdivo/Cabometyx group and 93% of the Sutent group, and grade 3 (severe)/4 (life-threatening) treatment-related side effects occurred in 68% and 55%, respectively. The most common treatment-related side effects of any grade were diarrhea (60% and 46%, respectively), palmar-plantar erythrodysesthesia (39% and 42%), hypertension (34% and 35%) and hypothyroidism (37% and 31%). Also, 22% of patients to receive Opdivo/Cabometyx were administered corticosteroids to manage immune-mediated side effects of any grade. Any grade treatment-related side effects led to discontinuation in 28% and 11%, respectively.

Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Final follow-up results from the CheckMate 9ER trial.” By Dr. Robert J. Motzer et al., 

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The combination of nivolumab and cabozantinib demonstrated superior long-term efficacy and manageable safety compared to sunitinib in untreated advanced renal cell carcinoma (RCC). The CheckMate 9ER trial showed improved progression-free survival, overall survival, and response rates with nivolumab/cabozantinib. The study included 651 patients, with significant benefits observed across various risk groups and metastatic sites. Common side effects included diarrhea and hypertension, with a higher incidence of severe side effects in the nivolumab/cabozantinib group. These findings support nivolumab/cabozantinib as a standard treatment for advanced RCC.

Opdivo plus Cabometyx resulted in a significant progression and survival benefits compared with Sutent in the first-line treatment of patients with advanced renal cell carcinoma.

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Opdivo Plus Cabometyx Safe, Effective in Advanced Renal Cell Carcinoma

, where you’ll learn practical strategies on how to advocate for people impacted by cancer at both the state and federal levels.

Advocacy plays a crucial role in driving change, particularly in health care. A new administration brings fresh opportunities for cancer patients, caregivers, and health care professionals to engage in advocacy. As policies affecting access to care, financial protections, and treatment options evolve, it’s vital for advocates to take action and ensure the voices of the cancer community are heard.

This webinar is open to anyone passionate about advocating for individuals diagnosed with cancer—whether you're a patient, caregiver, or health care provider. Your voice matters, and taking action to protect vital rights and resources is essential.

Join us for a free, online webinar on February 20, 2025 at 11am PT / 1pm CT / 2pm ET. 

Did you know Triage Cancer has free, monthly webinars open to anyone in the cancer community? Check out their

Advocacy is essential in influencing healthcare policies, especially for cancer patients, caregivers, and professionals. With a new administration, there are opportunities to engage in advocacy at state and federal levels, impacting access to care, financial protections, and treatment options. Triage Cancer offers a free webinar on February 20, 2025, to educate and empower individuals passionate about cancer advocacy. This event is open to patients, caregivers, and healthcare providers, emphasizing the importance of taking action to protect rights and resources within the cancer community.

Join Triage Cancer for their free webinar on Post-Election Advocacy: Getting Engaged.

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Learn to Advocate for the Cancer Community with Triage Cancer

Dr. Guru P Sonpavde discusses updated data from studies like EV-302 and CheckMate 274 for patients with urothelial cancer at the 2025 ASCO GU meeting.

An Expert Explains Updated Data For Patients With GU Cancers

Updated data from studies like EV-302 and CheckMate 274 were presented at the 

2025 ASCO Genitourinary Cancers Symposium

, reinforcing the role of their respective therapies among patients with urothelial carcinoma, according to Dr. Guru P Sonpavde.

Sonpavde sat down for an interview with CURE at the 2025 meeting to discuss the key takeaways from the meeting for patients with genitourinary cancers. He currently serves as the medical director of Genitourinary Oncology, is an assistant director of the Clinical Research Unit, and the Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, located in Orlando, FL.

I will say that the [data to come out of this meeting] is practice impacting, but not practice changing. This is because [we had confirming data]. For example, we had further follow-up on the EV 302 trial

 confirming the data for Padcev and Keytruda [enfortumab vedotin and pembrolizumab] as a first-line therapy in advanced urothelial carcinoma. One thing we saw in this study is the survival improvement holds up, with a complete response rate of about 30% and [it was reported] that the median duration of response is around 23 months, or close to two years, which was impressive. The duration of complete responses has still not been reached, which is also impressive, and hopefully it's more than [what we have seen, previously]. I believe that Padcev and Keytruda position’s itself as the preferred first-line therapy based on this longer follow up data.

Additionally, there was data [shared] on the treatment of adjuvant Opdivo [nivolumab] in the CheckMate 274 trial, which is already a positive trial for disease-free survival, and is FDA-approved in patients regardless of PD-1 status. This is approved as an adjuvant therapy for high-risk muscle invasive urothelial carcinoma. There was survival follow-up and it showed, of course, a significant trend for it's a secondary end point, but again, it [confirms] the position of adjuvant nivolumab in this adjuvant setting.

Transcript has been edited for clarity and conciseness.

Investigators are launching a global multi-regional phase 3 clinical trial that is to evaluate ASP-1929 photoimmunotherapy in combination with Keytruda (pembrolizumab) as a first-line therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), according to a news release from Rakuten Medical announced.

Furthermore, the first patient enrolled onto the trial recently received a study treatment at the Avera Cancer Institute in Sioux Falls, South Dakota. Patient enrollment is also planned for sites in Japan and Taiwan, with further expansion planned to other countries and regions.

"Photoimmunotherapy has a unique mode of action, which involves a biophysical disruption of targeted cells. [Keytruda] has become a mainstay in systemic treatment for recurrent/metastatic HNSCC,” Dr. Kristen Coffroth an expert in Head and Neck Surgery, Ear, Nose & Throat and Otolaryngology, at Avera Medical Group, and one of the investigators for the ASP-1929-381 study at the Avera Cancer Institute, stated in the news release. “This trial will evaluate whether the combination of ASP-1929 photoimmunotherapy with [Keytruda] can harness synergistic antitumor effects, which may shed new light on the treatment of locoregional recurrent HNSCC."

This study builds on interim evaluation data from 19 patients enrolled in the HNSCC cohort of a prior phase 1b/2 study, ASP-1929-181. The data indicated an estimated 24-month survival rate of 52.4%, with a generally tolerated safety and a median overall survival (OS) that was not reached. Specifically, there were no fatal serious side effects nor synergistic serious side effects reported due to ASP-1929 and anti-PD-1, though two life-threatening serious side effects were noted.

The phase 3 trial is evaluating ASP-1929 photoimmunotherapy plus anti-PD-1 Keytruda as a first-line treatment for recurrent, locoregional HNSCC without distant spreading of the disease. The randomized, open-label study will enroll approximately 400 patients globally, assigned to either the experimental treatment group, consisting of ASP-1929 photoimmunotherapy plus Keytruda, or the control therapy group, evaluating the Keytruda-based standard of care, which may include chemotherapy.

Patients will be enrolled onto the study and across three treatment groups: ASP-1929 PIT at doses of 320 milligrams per square meter (mg/m²) or 640 mg/m² combined with Keytruda, or a standard-of-care group where patients may receive Keytruda alone or Keytruda plus chemotherapy by a physician's choice.

The primary end goal of the study is OS, while secondary end goals include complete response rate and overall response rate.

According to the news release, ASP-1929 is an antibody-dye conjugate that binds to epidermal growth factor receptor (EGFR), a cancer antigen expressed in various solid tumors. After binding to cancer cells, ASP-1929 is activated by red light, causing damage to the cancer cell membrane and selective necrosis. In Japan, ASP-1929 received marketing approval for unresectable locally advanced or recurrent head and neck cancer in 2020. Outside Japan, it hasn’t been approved by any regulatory authority.

Dr. William Chad Spanos, an expert in Ear, Nose & Throat and Head and Neck Surgery, as well as the Principal Investigator for the ASP-1929-381 study at the Avera Cancer Institute, emphasized that he is, “…impressed by the technology behind photoimmunotherapy, which offers a novel and targeted approach to cancer treatment. Combining this with [Keytruda] has the potential to expand first-line treatment options for patients with recurrent HNSCC. I am pleased to initiate this groundbreaking trial at our site and look forward to contributing to advancing care for patients facing this challenging disease."

A global phase 3 clinical trial is underway to evaluate ASP-1929 photoimmunotherapy combined with Keytruda as a first-line treatment for recurrent head and neck squamous cell carcinoma (HNSCC). The trial, involving approximately 400 patients, aims to assess the synergistic antitumor effects of this combination therapy. ASP-1929, an antibody-dye conjugate targeting EGFR, is activated by red light to induce cancer cell necrosis. The study's primary endpoint is overall survival, with secondary endpoints including complete and overall response rates. ASP-1929 is approved in Japan but not elsewhere.

A phase 3 trial is evaluating ASP-1929 photoimmunotherapy plus Keytruda in first-line treatment for recurrent head and neck squamous cell carcinoma.

New Trial to Test Light Therapy Plus Keytruda in Head and Neck Cancer

Dr. Filippo Pietrantonio discusses OrigAMI-1 trial data which assessed Rybrevant in mutated, wild-type, non-HER2-amplified metastatic colorectal cancer.

Rybrevant Alone and in Combo With Chemo is Efficacious in HER+ mCRC

2025 ASCO Gastrointestinal Cancers Symposium

, investigators, such as Dr. Filippo Pietrantonio, shared data on the OrigAMI-1 trial which assessed Rybrevant (amivantamab) as a monotherapy and in combination with chemotherapy in patients with mutated, wild-type, non-HER2-amplified metastatic colorectal cancer (mCRC). In an interview with CURE, Pietrantonio broke down the data that were shared at the meeting.

The responses that patients had to treatment were durable, with median duration of response of 7.4 months with the monotherapy and 5.8 months for combination therapy. The safety profile was also consistent with previous findings, including things like rash and hypoalbuminemia as the most common grade 3 (severe) or higher side effects. As of August 26, 2024, 23 patients received the monotherapy, with an objective response rate (ORR) of 22% and a disease control rate (DCR) of 78%. Among seven patients receiving Rybrevant plus chemotherapy, the ORR was 43% and DCR was 86%.

Read more about next steps with the trial and insights from Pietrantonio, who serves as the Head of the Gastrointestinal Oncology Unit at Fondazione IRCCS Istituto Nazionale dei Tumori, in Milan, Italy, below!

Given the promising anti-tumor activity of Rybrevant in this patient population, two phase three trials are planned and are ongoing in patients with mCRC [whose disease has] KRAS and BRAF wild-type type status. OrigAMI-2 [will serve] as phase three study comparing doublet chemotherapy plus Rybrevant versus the same chemotherapy backbone plus cetaximab in patients with left-sided tumors. [Additionally], OrigAMI-3 is another phase 3 trial investigating Rybrevant irrespective of primary tumor location, so including patients with right-sided tumors. This phase three trial compares second-line treatment with [chemotherapy] plus Rybrevant versus the same chemotherapy regimen plus cetaximab or bevacizumab.

The [advantage] point of these trials is that a more convenient subcutaneous formulation of Rybrevant will be used. This is much more tolerable the intravenous formulation used in the previous studies, including OrigAMI-1, because of the lower incidence of infusion reactions. Improving the treatment compliance and tolerability is important for patients and for the overall safety profile of this novel combination, so we are [looking forward to] coupling a good safety profile with potentially higher efficacy.

The OrigAMI-1 trial evaluated Rybrevant (amivantamab) as a monotherapy and in combination with chemotherapy for metastatic colorectal cancer (mCRC) with specific genetic profiles. The trial demonstrated durable responses, with a median duration of response of 7.4 months for monotherapy and 5.8 months for combination therapy. Safety profiles were consistent with previous findings. Two phase three trials, OrigAMI-2 and OrigAMI-3, are underway to further assess Rybrevant's efficacy, utilizing a more tolerable subcutaneous formulation to improve patient compliance and safety.

Rybrevant Alone and in Combo With Chemo is Efficacious in Wildtype+ mCRC

One of the many issues that patients with cancer face is food insecurity and malnutrition, according to Dr. Anna Arthur, who added that based on this gap in the treatment space, investigators launched the NOURISH trial (Nutrition Outreach in Systems of Healthcare) which will investigate the impact of addressing these needs among patients with blood cancers undergoing transplant or cellular therapy.

“We know that individuals who are diagnosed with cancer and going through treatment are at higher risk of compromised nutritional status and malnutrition compared with healthy individuals without cancer,” said Arthur,   the study’s primary investigator, in an interview with CURE®.

In the interview, Arthur delved into insights on the NOURISH trial and highlighted the importance of addressing food insecurity and malnutrition in patients with cancer. She also shared what types of foods are most important for patients with cancer to consume during their treatments.

Arthur is currently the Director of the Medical Nutrition Science Program, as well as a tenure-track Assistant Professor in the Department of Dietetics and Nutrition at the University of Kansas Medical Center.

: How does food insecurity impact cancer treatment outcomes overall for patients?

: Patients [with cancer] who start treatment malnourished, or who become malnourished during their cancer treatment, are at higher risk of several different negative outcomes. These [outcomes] include reduced quality of life; increased susceptibility to infection and illness; increased hospital admissions, as well as increased time spent in the hospital if they're admitted; and reduced tolerance to cancer treatment. This could lead to things like treatment breaks, delays in initiating their treatment, dose reductions in the treatment that they're receiving, or even in severe cases, early cessation of treatment.

These factors also put these individuals at higher risk of morbidity and mortality. When a patient [has] a cancer diagnosis and [is] going through cancer treatment, [they are more likely to be] at a higher risk of compromised nutrition, if they are also food insecure and unable to afford or access the food that they need to help maintain their nutritional status during treatment. This [is] an added obstacle in the prevention of malnutrition and optimizing nutritional status.

What types of foods are most important for patients with cancer to consume during their treatments? Which nutrients might act like fuel for the body to recover during treatment?

There are recommendations that we give to patients with cancer during treatment for dietary intake, as well as how we prioritize types of medical nutrition therapy interventions that we provide. [These recommendations are highly] individualized; [they] vary depending on what type of cancer patients have, what stage the cancer is when diagnosed, the type of treatment that they're going to receive and other health conditions that they may be presenting with.

For patients with cancer that are at high risk for malnutrition, focusing on foods that are high in calories and high in protein are often prioritized to help minimize weight loss and with maintenance and prevention of muscle mass loss. We know that weight loss, especially in the form of muscle loss, during cancer treatment, is associated with those [poor] outcomes. Therefore, maintaining the adequate intake of calories and protein during cancer treatment can help reduce the risk of those negative outcomes, minimize that weight loss and preserve muscle mass. [This is] so that the patient can better tolerate their treatment, enhancing their recovery after treatment.

How does the NOURISH trial aim to simplify the process of accessing nutritious foods for these patients?

We'll be providing patients with bags of food that are provided by our food bank partners at each of the four cancer centers that we are doing this trial at. We're working in Kansas City with Harvesters Food Bank, and these food bags will provide enough food for two to three days of balanced nutrition for one person. When patients come into clinic for their cancer treatment, they'll receive their bags in a discrete manner, and they'll also be receiving bags two times per week.

We anticipate, by providing the food bag when they come in for their cancer treatment, we're ensuring that they have the food that they need to maintain their nutritional status, and that avoids having to procure the food themselves, either at a grocery store or at a food pantry, which can be a really major burden during a very stressful time in their life, when patients are not feeling well. Additionally, [if the patients are] food insecure, they may also lack resources like money and transportation to be able to go out and get food on their own.

In addition to the food bags, we’re providing patients with recipes and video cooking demonstrations in the bag and on a centralized website so that patients and their care partners can know and don't have to figure out on their own how to use the content of the bags that they receive. [This] helps them manage the side effects they may be experiencing so that they can get the nutrition that they need, even if they are experiencing symptoms and side effects.

How do you envision it influencing cancer care and health system policies in the future, particularly regarding food insecurity and malnutrition in these patients?

I'm hopeful that we will be successful in demonstrating positive outcomes; the positive outcomes that we're mainly looking at are cost effectiveness as well as reduced malnutrition or preventing malnutrition.

This trial could then pave the way for other health systems and cancer centers around the country to provide a similar program to patients who need it as part of their standard of care. That would be beneficial for food insecure patients, and maybe even someday, we could reach a point where we could provide food for all patients with cancer, regardless of food insecurity.

Why is it important for patients with cancer undergoing transplant or cellular therapy to prioritize calorie and protein intake, even if it means adjusting their normal, healthy diet?

As a registered dietitian and nutritionist, I am trained to prioritize nutrition problems that patients come to us with based on what the most urgent need is the. During cancer treatment, often the most urgent need is to prevent or treat malnutrition and help manage side effects, preventing the loss of muscle mass.

Cancer treatment is not the time to focus on losing weight. While we still must be attentive to other nutrition-related issues that the patients may present to us with, like diabetes or high cholesterol or micronutrient deficiencies, minimizing weight loss and muscle mass loss during cancer treatment is the highest priority, even in patients who are overweight or obese.

Addressing food insecurity and malnutrition is crucial for cancer patients, particularly those undergoing transplant or cellular therapy. The NOURISH trial aims to assess the impact of providing nutritious food to these patients, potentially improving treatment outcomes and reducing negative effects like increased hospital admissions and treatment delays. High-calorie and high-protein foods are emphasized to prevent weight and muscle loss. The trial also seeks to simplify food access through partnerships with food banks, offering food bags and educational resources. Success could influence future cancer care policies and standard practices.

Dr. Anna Arthur discusses how the NOURISH trial is addressing food insecurity and malnutrition in patients undergoing treatment for their blood cancers.

Dr. Rohan Garje

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