A nationally-published, award-winning journalist, Alex Biese joined the CURE team as an assistant managing editor in April 2023. Prior to that, Alex's work was published in outlets including the Chicago Sun-Times, MTV.com, USA TODAY and the Press of Atlantic City. Alex is a member of NLGJA: The Association of LGBTQ+ Journalists, and also performs at the Jersey Shore with the acoustic jam band Somewhat Relative.

Alex Biese

There were a number of notable developments for patients with kidney cancer at the symposium: © SciePro - stock.adobe.com

At the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, there were a number of notable developments for patients with kidney cancer, Dr. Emre Yekedüz explained in an interview with CURE.

Yekedüz is a medical oncologist and research fellow in medicine at Dana-Farber Cancer Institute in Boston.

CURE: What were the most important takeaways from the symposium regarding kidney cancer treatment?

: I can name the three most important key takeaways for our patients from 

. The first promising advancement is the combination regimen of Lenvima (lenvatinib), a tyrosine kinase inhibitor used in kidney cancer patients, and Welireg (belzutifan), a HIF-2α inhibitor also used in kidney cancer. This combination shows promise in second-line treatment and beyond for patients with metastatic clear cell RCC.

The second advancement is KIM-1, the kidney injury molecule-1, a promising biomarker for evaluating prognosis and predicting survival in metastatic clear cell RCC patients receiving Opdivo (nivolumab) plus Yervoy (ipilimumab). These are the immune checkpoint inhibitors used in our kidney cancer patients.

The third is a novel HIF-2α inhibitor, a target for kidney cancer patients. Casdatifan is currently under development. An early phase 1 trial, presented by Dr. Toni Choueiri, showed a 30% objective response rate as a single agent in second-line treatment and beyond for patients with metastatic clear cell renal cell carcinoma (RCC). We are now awaiting other combinations in phase 3 trials. This is a novel and promising agent for our kidney cancer patients.

Objective response rate: patients who responded partially or completely to treatment.

Complete response: the disappearance of cancer.

Were there any significant advancements in targeted therapies or immunotherapy for kidney cancer presented at the symposium?

The first promising development is the Lenvima plus Welireg combination. Lenvima is a tyrosine kinase inhibitor, and Welireg is a HIF-2α inhibitor. This combination has a 47% objective response rate in a phase 2 trial, suggesting it's a promising treatment for previously treated metastatic clear cell RCC patients. Based on these results, we are awaiting the LITESPARK-011 trial. This phase 3 trial compares the Lenvima plus Welireg combination versus Cabometyx (cabozantinib), another tyrosine kinase inhibitor, in previously treated metastatic clear cell RCC patients. We are very excited about this combination for our patients.

The second advancement is Lenvima, the tyrosine kinase inhibitor, plus Tevimbra (tislelizumab), an immune checkpoint inhibitor. This combination is being explored in fumarate hydratase-deficient RCC, a very rare subtype of non-clear cell RCC. We categorize RCC patients into clear cell and non-clear cell, and the non-clear cell group includes very rare subtypes. Fumarate hydratase-deficient RCC accounts for approximately 1% to 2% of all cases. A phase 2 trial evaluating Lenvima plus Tevimbra demonstrated an extremely high objective response rate, almost 90%, with 20% of patients achieving a complete response, meaning no primary disease progression. All patients achieved disease control, and this combination may be a promising first-line standard of care treatment option for patients with fumarate hydratase-deficient RCC.

ctDNA and biomarkers in this treatment field are gaining attention and have been for a while now. What role do these play in kidney cancer treatment, and can they help guide personalized treatment?

ctDNA is a really useful biomarker in all types of cancer. We can use ctDNA for cancer screening, early cancer detection, from diagnosis to the metastatic stage; we can use it at every step during the cancer course. Numerous trials and studies are ongoing. However, we still need time to use it in our clinical practice for kidney cancer patients. But we can ask some questions about how we can use ctDNA in our patients. The first question is: Is there any role for ctDNA in small renal masses, and can we use it to select patients for surgery, other local ablative therapies, or observation? The second question is: Can we use ctDNA to select patients after surgery to give them adjuvant Keytruda (pembrolizumab)? Adjuvant Keytruda is a standard of care in the adjuvant setting to prevent disease recurrence. So, can we use ctDNA to select patients for adjuvant Keytruda or observation? And the third question is: Can we use ctDNA in the metastatic setting for prognosis or predicting treatment response?

In light of these questions, there was a trial presented at ASCO GU 2025, the CALYPSO trial. This phase 2 trial evaluated the efficacy of Imfinzi (durvalumab), an immune checkpoint inhibitor, plus savolitinib, a c-MET-targeted tyrosine kinase inhibitor, in patients with papillary cell RCC. The exploratory analysis of this trial showed that baseline ctDNA and ctDNA clearance were prognostic, and high ctDNA levels were associated with worse survival outcomes. We need further studies and study designs to use ctDNA in our daily clinical practice for kidney cancer patients.

When it comes to biomarkers, KIM-1, kidney injury molecule-1, is a really promising biomarker, and we are very excited about it in kidney cancer. Previously, its prognostic role in the metastatic setting and its use for predicting disease recurrence in the adjuvant setting were shown in different studies. Now, at ASCO GU 2025, Dr. Wenxin Xu from Dana-Farber Cancer Institute presented the results of baseline KIM-1 and decreasing KIM-1 levels with treatment in the CHECKMATE-214 trial, involving patients receiving the Opdivo plus Yervoy combination.

Based on the results, if we see a good response in KIM-1 levels in the third week of treatment, we can say that the prognosis is good with Opdivo plus Yervoy treatment. However, if we don't see any response, can we say that the prognosis is poor, and should we change or intensify our treatment with other regimens or combinations? The results are promising, but we need more data and prospective evaluation of these findings in a clinical trial to make decisions about treatment selection and intensification.

This transcript has been edited for clarity and conciseness.

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Articles

Recent advancements in kidney cancer treatment were highlighted at the 2025 ASCO Genitourinary Cancers Symposium. Key developments include the promising combination of Lenvima and Welireg for metastatic clear cell RCC, and the potential of KIM-1 as a prognostic biomarker. Additionally, the novel HIF-2α inhibitor, casdatifan, showed a 30% response rate in early trials. The symposium also discussed the role of ctDNA in guiding personalized treatment, with the CALYPSO trial indicating its prognostic value. These findings underscore the evolving landscape of targeted therapies and biomarkers in kidney cancer management.

There were a number of notable developments for patients with kidney cancer at the symposium, Dr. Emre Yekedüz explained.

What Patients With Kidney Cancer Need to Know From ASCO GU

Dr. Regina Hampton discusses key factors contributing to this disparity, and how healthcare systems can address these challenges.

Research Shines Light on Disparities Across Breast Cancer Care 

Black women are approximately 40% more likely to die due to their breast cancer diagnosis compared with their White counterparts, according to the Mass General Brigham website, which goes on to state that this number can be as high as 50% depending on the type of breast cancer.

In a study which was led by Mass General Brigham researchers and published in 

, these higher mortality rates can be partially attributable to factors such as socioeconomic inequality, delays in diagnosis and inadequate access to timely quality cancer treatment. To note, these factors are independent of tumor biology, according to the research.

Dr. Regina Hampton, a breast surgeon and the chief of Breast Surgery at Doctors Community Medical Center, Luminous Health, in Lanham, Maryland, sat down for an interview with CURE where she discussed key factors contributing to this disparity, and how healthcare systems can address these challenges.

Black women that develop breast cancer tend to be pretty unique in that they [typically] develop breast cancer at younger ages, oftentimes under the age of 50, when in the general population, we often see it over the age of 60. When these women are young, and especially if they're under the age of 40, it presents a challenge because they're not at the age when we would recommend getting mammograms. We usually recommend getting mammograms starting at age 40.

A young woman who's in her 30s who comes in with a breast mass and is African American, oftentimes many providers say, “You're not 40. You don't need a mammogram. Come back at 40.” [This is an unmet need because we then] are missing a lot of breast cancers. One of the challenges is that not enough people, patients and providers, understand the uniqueness of African American women [presenting] at a younger [age], so we can't miss that opportunity.

There have been some who've advocated that we should look at doing more population-specific screening guidelines so that we can hopefully catch more of these breast cancers. I think the other thing is, as we see in other disease states, many times African American patients are not seen or heard when they do have complaints. I think it's been well covered throughout the media about different biases.

[Many times] it is a lot of miseducation and people not understanding or taking the time to see and hear [their] patient, which is a whole other part of the medical system that I think we're all really struggling with.

Transcript has been edited for clarity and conciseness

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Videos

CURE spoke with Leslie Waltke about the importance of physical therapy during a cancer journey.

Why Physical Therapy Should Begin at the Time of a Cancer Diagnosis

For patients with cancer, discussions about physical therapy should begin at the time of diagnosis, as Leslie Waltke explained in an interview with CURE.

“If somebody has a back surgery, a knee surgery, a stroke, we don't wait six months to start physical therapy,” said Waltke. “We don't wait for people to have more and more problems before we initiate care.”

Waltke, a member of CURE’s advisory board, is a physical therapist and the founder of the Waltke Cancer Rehabilitation Academy based in Milwaukee. She spoke with CURE about the critical role physical therapy can play at the beginning of a cancer journey.

 For patients with cancer, when is the right time to start talking about physical therapy with their care team

 At the beginning. So, if somebody has a back surgery, a knee surgery, a stroke, we don't wait six months to start physical therapy. We don't wait for people to have more and more problems before we initiate care. So, we really want physical therapy to begin right at the time of diagnosis, called peri-diagnosis or around diagnosis.

And every cancer has kind of a different starting point. Sometimes it's surgery, sometimes it's chemotherapy and/or radiation. But regardless of what the first cancer treatment is, that treatment, whether it’s surgery, chemotherapy or radiation, they all are well-known to create probable side effects that are going to affect skin, function, fatigue, energy, balance, strength, range of motion, all of those things that make us who we are. And we can either, with physical therapy early on, minimize those things, eliminate them or prevent them from happening in the first place.

This is all research based. We've studied this — so [we know] people who start physical therapy early do better than those who don't at all, and certainly do that better than those who start later. So, we really want again, regardless of whatever the first treatment is, that's when your physical therapy should start. Now, some people may have surgery first, and they don't have any problems. They come out of surgery, they don't have any pain, they don't have any limitations. They're like, “I feel great,” and that's fantastic. So they get dumped off the physical therapy train. But most people who have surgery are followed either with chemotherapy and/or radiation, and those treatment modalities can, again, create a completely different side effect profile.

So regardless of what you start with first, you want to have your physical therapist stay with you after surgery, during radiation, after radiation, during chemotherapy, after chemotherapy, and then certainly long into survivorship to help minimize loss, maintain strength, maintain function, keep you healthy, keep you strong, keep you pain free.

One of the largest or biggest terrifying moments for somebody when they hear the words “You have cancer” certainly is, “I don't want to die,” but also “I don't want to lose who I am.” I want to keep my job. I want to keep working. I want to stay independent. I don't want to have pain. I don't want to lose. And again, the best way to do that is with a physical therapist.”

Transcript has been edited for clarity and conciseness.

Initiating physical therapy at the time of cancer diagnosis is crucial for optimizing patient outcomes. Early intervention can help mitigate or prevent side effects associated with cancer treatments such as surgery, chemotherapy, and radiation. These treatments often impact skin, function, fatigue, energy, balance, strength, and range of motion. Research supports that patients who begin physical therapy early fare better than those who delay or forgo it. Continuous physical therapy throughout treatment and into survivorship helps maintain strength, function, and overall quality of life, addressing patients' fears of losing independence and identity.

Sonnet BioTherapeutics reports positive safety results from a phase 1 trial of SON-1010 combined with trabectedin for advanced leiomyosarcoma or liposarcoma, with no unexpected toxicities.

A clinical trial has reported positive safety findings of SON-1010 among adult patients with advanced leiomyosarcoma (LMS) or liposarcoma (LPS).

Findings from first safety review of the expansion cohort of the phase 1 SB101 clinical trial were announced in a news release from Sonnet BioTherapeutics Holdings, Inc., a clinical-stage company that is developing targeted and immunotherapeutic drugs.

SON-1010, as explained by the National Cancer Institute, is a targeted immunotherapy utilizing an engineered form of the cytokine interleukin-12 (IL-12) to activate a patient’s immune system in order to kill tumor cells and inhibit tumor cell proliferation.

The SB101 Safety Review Committee found that among patients in the study’s expansion cohort, who are receiving SON-1010 in combination with Yondelis (trabectedin) chemotherapy, after an average treatment of more than two months one patient had progressed and six were reported to be tolerating treatment. According to the news release, the Safety Review Committee found no unexpected toxicities in the first seven patients at the maximum tolerated dose.

“Our physicians are always working to improve the outcomes in sarcoma and very pleased to continue to support the expanded SB101 trial,” commented Dr. Sant Chawla, principal investigator at the Sarcoma Oncology Center in Santa Monica, California. “We have a wealth of experience with [Yondelis] and believe that SON-1010 has the ability to improve its therapeutic effectiveness, given that SON-1010 as a clinical trial monotherapy has already demonstrated clinical benefit in advanced sarcoma patients, including a partial response. LPS and LMS are the most common types of sarcoma, which are difficult diseases to treat. While the approval of [Yondelis] in the U.S. has helped, there is room for improvement in all types of STS and the drug appears to have utility in the relapsed ovarian cancer setting as well. The safety of SON-1010 in combination with [Yondelis] is encouraging at this stage and we look forward to the results from the larger group of patients for further clinical trials.”

Partial response: a decrease in the extent of cancer in the body in response to treatment.

The SB101 clinical trial is currently recruiting, according to its listing on clinicaltrials.gov, with an estimated eventual enrollment of 36 patients.

Side effects that were considered to be related to either drug were all mild or moderate. The annual review that included all 30 patients dosed to date in the study revealed that common side effects considered related to SON-1010 as a standalone or combination therapy were fatigue, fever, chills and myalgia in 15% or more, with moderate fatigue being the only related side effect in two or more patients who had also received treatment with Yondelis.

The news release further reported that five of the six patients (83%) in the high-dose SON-1010 monotherapy group showed stable disease at four months, with four patients continuing on the trial at six months with no new safety concerns and a partial response in one of those patients persisting. Thirteen of the 24 patients (54%) who were studied during SON-1010 dose escalation were found to have evidence of clinical benefit from SON-1010 monotherapy.

“The goal for the expansion cohort is to assess combination therapy in earlier-stage patients with [soft-tissue sarcomas], which provides an exciting opportunity to evaluate the potential for SON-1010 to turn ‘cold’ tumors ‘hot’ and improve the response of trabectedin in a licensed chemotherapy indication,” added Pankaj Mohan, Sonnet founder and CEO. “We believe the results of this expansion cohort will position SON-1010 for a larger Phase 2 study that could establish the combination of SON-1010 and trabectedin as a new and potentially improved treatment for STS at an earlier stage.”

A clinical trial has shown promising safety results for SON-1010 in patients with advanced leiomyosarcoma or liposarcoma. SON-1010, an engineered interleukin-12 cytokine, is being tested in combination with Yondelis chemotherapy. The trial's Safety Review Committee reported no unexpected toxicities at the maximum tolerated dose, with most side effects being mild or moderate. The trial aims to assess the combination therapy's potential to enhance treatment efficacy in soft-tissue sarcomas, with plans for a larger Phase 2 study to further evaluate its effectiveness.

A phase 1 trial has reported positive safety findings of SON-1010 among patients with advanced leiomyosarcoma (LMS) or liposarcoma (LPS).

Alex Biese

What Patients With Kidney Cancer Need to Know From ASCO GU

Research Shines Light on Disparities Across Breast Cancer Care

Why Physical Therapy Should Begin at the Time of a Cancer Diagnosis

SON-1010 Generates Safe Results in Advanced Sarcoma

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