On October 28, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint.

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"KEYTRUDA monotherapy given in the adjuvant setting remains an important treatment choice for patients with renal cell carcinoma at an increased risk of recurrence following surgery and is the only approved option to have significantly improved disease-free survival and overall survival in this disease setting. Still, many of these patients do remain at risk of recurrence and continue to represent an unmet need," said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. "These encouraging results of KEYTRUDA in combination with WELIREG from LITESPARK-022 demonstrate the potential to provide additional treatment options for those most in need."

The safety profiles of KEYTRUDA plus WELIREG in this trial were overall consistent with those observed in previously reported studies for the individual therapies. Results will be presented at a future medical meeting and shared with regulatory authorities worldwide.

KEYTRUDA is approved for the adjuvant treatment of certain patients with RCC in the U.S., Canada, European Union (EU), Japan and other countries worldwide based on data from KEYNOTE-564.

WELIREG is approved in over 40 countries including the U.S., Canada, EU, and Japan for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

Merck has an industry-leading clinical development program in RCC, leveraging multiple approved therapeutic options across multiple settings, including adjuvant and advanced disease.

About LITESPARK-022
LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to KEYTRUDA plus placebo for the treatment of patients with clear cell RCC following nephrectomy. The primary endpoint is DFS; the key secondary endpoint is OS; other secondary endpoints include safety and quality of life outcomes. The trial enrolled 1,841 patients who were randomized to receive either:

WELIREG (120 mg orally once daily for approximately one year), plus KEYTRUDA (400 mg intravenously every six weeks for approximately one year) or;
KEYTRUDA plus oral placebo.
About renal cell carcinoma
Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnoses and approximately 156,000 deaths from the disease worldwide. RCC is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Merck & Co, OCT 28, 2025, View Source [SID1234657070])

On October 28, 2025 Ferring Pharmaceuticals reported that three abstracts featuring ADSTILADRIN (nadofaragene firadenovec-vncg) will be presented at the 101st Annual Meeting of the Western Section of the American Urological Association (AUA) being held November 2-6 in Napa, CA. ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the U.S. Food and Drug Administration (FDA) for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

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A Ferring-sponsored study will present baseline characteristics and demographics from the initial patient cohort enrolled in ABLE (ADSTILADRIN in BLadder CancEr)-41, a Phase 4 multicenter non-interventional study examining the use of ADSTILADRIN in a real-world setting. In addition, two independent real-world studies will be presented. This includes a study analyzing electronic billing records for 101 patients from 19 U.S. medical centers who received ADSTILADRIN and is exploring durability of remaining on ADSTILADRIN, and lack of progression to radical cystectomy. A third abstract is a case series evaluating re-induction with ADSTILADRIN among 17 patients across 8 academic and community settings, the findings of which were published recently in The Journal of Urology.

"Real-world evidence provides an important view of how a treatment like ADSTILADRIN is being used in routine practice," said Sia Daneshmand, MD, Professor of Urology and Medicine (Oncology) and Director of Urologic Oncology at Keck School of Medicine of University of Southern California. "The ABLE-41 study will add to this evidence by capturing early insights from a broader, more diverse patient population than prior trials, helping us understand patient experiences and inform care for those with BCG-unresponsive NMIBC."

"ADSTILADRIN is an important option for uro-oncologists, offering an effective and convenient quarterly dosing schedule administered in the urologist’s office, and a non-chemotherapy alternative to radical cystectomy," said Daniel A. Shoskes, MD, FRCS(C), Vice President, Global Medical Director- Uro-Oncology, Ferring Pharmaceuticals. "The ongoing research exploring the real-world use of ADSTILADRIN adds to the body of evidence in NMIBC patients who no longer respond to BCG. I am thrilled that this research is also exploring treatment re-induction, helping to build on the strong foundation of our Phase 3 program and further inform care for NMIBC patients."

About ADSTILADRIN Presentations at the Western Section AUA

ADSTILADRIN poster titles and presentation times at 101st Annual Meeting of the Western Section AUA, November 2-6, 2025, are:

ABLE-41, a real-world evidence study for bladder cancer patients treated with nadofaragene firadenovec: baseline patient characteristics and demographics. Abstract #257 (Poster #23), November 2, 2025, 7:00-9:00 a.m. PST
Real-world utilization of ADSTILADRIN in patients with BCG-unresponsive non-muscle invasive bladder cancer. Abstract #242 (Poster #18), November 2, 2025, 7:00-9:00 a.m. PST
Re-induction with nadofaragene firadenovec for BCG-unresponsive NMIBC: real-world data from a multicenter cohort. Abstract #301 (Poster #11), November 2, 2025, 7:00-9:00 a.m. PST
About ABLE-41

ABLE-41 is a non-interventional study following NMIBC patients aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. In September 2023, Ferring announced the first patient enrolled in ABLE-41. Eligible patients include those who were prescribed and scheduled to receive treatment, per their physician’s discretion, or patients who received their first instillation (per physician discretion) after September 5, 2023, but before the site was activated in the trial.

The primary objective is to assess whether patients achieve a complete response (CR) at three months and/or at any time within a year of their first instillation.

Participants in ABLE-41 will be followed for 24 months, or until study discontinuation or withdrawal. Key secondary outcomes include the following: treatment patterns of use; duration of CR; recurrence-free survival, cystectomy-free survival, progression-free survival, overall survival, and bladder cancer–specific mortality; patient, caregiver, and physician experiences; adjunctive use of molecular markers; and safety. Patient experiences will be assessed with a commonly used quality of life questionnaire (EuroQol 5 Dimension 5 Level), measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Caregiver experiences will be measured with the Work Productivity and Activity Impairment questionnaire, adapted for caregiving, which assesses the impact of health problems on paid and unpaid work.

Results from this prospective, multi-institutional study are expected at the end of 2026. Learn more at www.clinicaltrials.gov/study/NCT06026332.

About ADSTILADRIN

ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology).

(Press release, Ferring Pharmaceuticals, OCT 28, 2025, View Source [SID1234657086])

On October 28, 2025 Starpharma reported Quarterly Activities Report and Appendix 4C for the quarter ended 30 September 2025 (Q1 FY26).

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(Press release, Starpharma, OCT 28, 2025, View Source,and%20executive%20directors%20of%20$355%2C000. [SID1234661699])

On October 28, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported updated results from the single-arm squamous cell anal carcinoma (SCAC) cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq) in patients with ≥2L metastatic SCAC. Patients from this cohort continue to be followed, and additional efficacy data are expected to be reported.

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The combination of pelareorep and atezolizumab achieved an objective response rate (ORR) of 30% (six among 20 evaluable patients). This represents a greater than 2x improvement over the historical benchmark of 13.8% ORR reported for the only FDA-approved immunotherapy for 2L SCAC.

Importantly, there have been two durable complete responses among the six responders, with one ongoing beyond two years, and the other lasting 15 months. In addition, another patient has an ongoing response at 64 weeks. The overall median duration of response for patients receiving pelareorep and atezolizumab is 15.5 months compared to 9.5 months for the current standard of care at this stage of treatment.

These updated results from this ongoing SCAC cohort reinforce the potential of pelareorep to drive durable immunologic tumor control in gastrointestinal tumors. The results also demonstrate the durability and depth of responses achievable with the combination of pelareorep and checkpoint inhibitors without chemotherapy.

"This is the most encouraging efficacy signal with a non-chemo regimen we have ever seen in anal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. "Achieving a 30% objective response rate — more than double the benchmark of the only approved immunotherapy — along with multiple responses lasting more than a year, including two complete responses, underscores pelareorep’s ability to unlock deep and durable immune responses. We believe the data represent our best chance to obtain an accelerated approval in a rare disease with virtually no options outside of chemotherapy."

The SCAC cohort is part of Oncolytics’ broader GOBLET study, a Phase 1/2 trial evaluating pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications, including pancreatic, colorectal, and anal cancers.

Based on these compelling data, Oncolytics intends to engage the U.S. Food and Drug Administration (FDA) to discuss a potential single-arm study designed for accelerated approval in second-line or later SCAC, with a potential launch date for such a study expected in the first half of 2026.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

(Press release, Oncolytics Biotech, OCT 28, 2025, View Source [SID1234657071])

On October 28, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported another successful readout for its ECD program, which is evaluating a blood-based screening test for the detection of CRC and advanced adenomas (AA). This latest analysis from the U.S. based, prospective PROCEED-CRC clinical trial (NCT06620627) focused on the detection of AAs, which are precancerous polyps with specific features that indicate a higher risk of progression to colorectal cancer. Detecting these lesions early is a critical step in preventing cancer before it develops.

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PROCEED-CRC has enrolled approximately 5,000 average-risk asymptomatic screening participants with blood draws taken pre-colonoscopy. This analysis started with approximately 1,400 PROCEED-CRC cases that were collected prior to the cutoff date, incorporating 92 sequentially collected AA samples and a representative cohort of 366 normal controls. The study showed sensitivity of 22.5% (CI: 15.4%-32.4%) and specificity of 91.5% (CI: 88.2%-93.9%)​​ and encompassed all histologic subtypes, including serrated polyps. When adjusted for subtype prevalences found in two recent CRC screening FDA-enabling trials1,2, sensitivity was 22.4% and 23.7%. Additionally, in this study, 98.9% of AA cases were less than 30 millimeters and 93.5% were below 20 millimeters, which represents a challenging size distribution because smaller lesions can be more difficult to detect.

Earlier in 2025, Natera reported preliminary AA performance data from a pilot study with 18% sensitivity and 91% specificity. Since that time, several technology changes have resulted in improved assay performance. These findings create increased confidence going into the FIND clinical trial (NCT07046585), an FDA-grade validation study, which was initiated in 2025 and continues to make significant progress.

"This data represents another important milestone in our efforts to advance blood-based colorectal cancer screening," said Alexey Aleshin, M.D., general manager of oncology and early cancer detection, and chief medical officer at Natera. "Detecting advanced adenomas is critical for intercepting colorectal cancer before it develops, and this exceptional performance highlights the strong potential of our technology to transform early detection."

These results build on previously reported case-control data from screen-detected CRC cases, which were also announced earlier this year showing overall sensitivity of 95% (95% CI: 92-99%) and specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals.

(Press release, Natera, OCT 28, 2025, View Source [SID1234657087])