Zumrad (sasanlimab) / Pfizer - LARVOL DELTA

MODULE 1: Optimal Use of Anti-PD-1/PD-L1 Antibodies for Non-Muscle-Invasive Bladder Cancer (NMIBC) (ASCO-GU 2026) - "This event is organized and accredited by Research To Practice and supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc. Rationale for the evaluation of anti-PD-1/PD-L1 antibodies in combination with BCG for patients with BCG-naïve high-risk NMIBC Design, eligibility criteria and key endpoints of the Phase IIICREST, POTOMAC and ALBAN studies evaluating sasanlimab, durvalumab and atezolizumab, respectively, in combination with BCG for BCG-naïve high-risk NMIBC Published efficacy and safety data with sasanlimab, durvalumab and atezolizumab, respectively, combined with BCG in the CREST, POTOMAC and ALBAN studies Recent positive outcomes with durvalumab in combination with BCG from the POTOMAC study Potential role of anti-PD-1/PD-L1 antibodies combined with BCG for BCG-naïve high-risk NMIBC Long-term findings with pembrolizumab monotherapy for patients with BCG-unresponsive high-risk NMIBC; optimal..."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SPARCC: A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Stephanie Berg | Not yet recruiting ➔ Recruiting

Enrollment open • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • TFE3 • TFEB

Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial. (PubMed, Nat Med) - P3 | "Sasanlimab combined with BCG-I+M has the potential to redefine the treatment paradigm and clinical decision-making for patients with BCG-naive high-risk NMIBC. ClinicalTrials.gov identifier: NCT04165317 ."

Journal • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Immune-mediated adverse events (imAEs) associated with sasanlimab in combination with Bacillus Calmette-Guérin (BCG): Phase III study (CREST) (ESMO 2025) - P3 | "Conclusions imAEs seen with sasanlimab in combination with BCG were aligned with the known safety profile of ICIs. imAEs were manageable with treatment interruption/discontinuation and administration of corticosteroids and/or hormonal replacement therapy."

Adverse events • Combination therapy • P3 data • Oncology

Sasanlimab as bladder-sparing maintenance treatment after neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (MIBC): The phase 2, SASAN-SPARING trial. (ASCO 2025) - P2 | "Patients are ≥ 18 years, ECOG 0-1 and treatment-naïve for MIBC candidates to receive neoadjuvant cisplatin/gemcitabine followed by RC. Study of biomarkers will provide a useful tool to corroborate achievement of a clinical complete response, contributing to personalized treatments. The study is approved and started with recruitment of patients in December 2024."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an in situ vaccine for cisplatin-ineligible muscle invasive bladder cancer: The RAD VACCINE MIBC clinical trial. (ASCO-GU 2026) - P2 | "In situ vaccination (SBRT with ICI) achieved a meaningful pCR rate with acceptable toxicity in CNAC ineligible MIBC. These promising clinical and mechanistic findings support this strategy in future trials with other systemic agents to improve pCR with the potential for improved distant control, and organ preservation."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD4

A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene. (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=190 ➔ 26

Enrollment change • Enrollment closed • IO biomarker • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • KRAS • ROS1

Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. (ASCO 2025) - P3 | "Sasanlimab in combination with BCG (IND and MNT) improved EFS outcomes in the overall population and in the subgroups of pts with BCG-naive, high-risk NMIBC who had CIS or T1 tumors at randomization. This post hoc analysis further supports the potential of sasanlimab in combination with BCG as a practice-changing treatment in pts with aggressive disease."

Combination therapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): SASANLIMAB IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN IMPROVES EVENT-FREE SURVIVAL VERSUS BACILLUS CALMETTE-GUÉRIN AS STANDARD OF CARE IN HIGH-RISK NON- MUSCLE-INVASIVE BLADDER CANCER: PHASE 3 CREST STUDY RESULTS (AUA 2025) - P3 | "Sasanlimab in combination with BCG-I+M outperformed the current SOC of BCG-I+M with a manageable safety profile and has the potential to change the treatment paradigm for BCG-naive, HR NMIBC."

Clinical • Combination therapy • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Cost-Effectiveness Analysis of Sasanlimab plus BCG for High-Risk Non-muscle Invasive Bladder Cancer (NMIBC): Analysis From CREST (AUA 2026) - No abstract available

Cost effectiveness • HEOR • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Thematic Session - BCG meets immunotherapy in high-risk NMIBC: Key lessons for urologists from POTOMAC, ALBAN, and CREST (EAU 2026) - "The POTOMAC, ALBAN, and CREST trials evaluated the addition of durvalumab, atezolizumab, and sasanlimab, respectively, to BCG in patients with BCG-naïve high-risk NMIBC. However, several factors — including the quality and completeness of (re-)TURBT, the BCG strain and treatment schedule used, and heterogeneity in study endpoints — may introduce bias. In this session, we will discuss these potential biases and their clinical implications."

Bladder Cancer

Trial highlights: CREST — Sasanlimab + BCG (Positive) (EAU 2026) - No abstract available

Bladder Cancer

SASAN-SPARING: A phase 2 trial of sasanlimab maintenance as bladder-sparing option after neoadjuvant chemotherapy in patients with muscle invasive bladder cancer. (ASCO-GU 2026) - P2 | "The study follows an adaptive treatment strategy, where patients receive four cycles of neoadjuvant chemotherapy consisting of cisplatin (70 mg/m2, day 1), and gemcitabine (1000 mg/m2, days 1 and 8) every three weeks. A total of 70 patients are planned for enrollment, assuming a 12-month biOS of 81% (H0) and an increase with sasanlimab up to 93% (H1) (one-arm survival test; α = 0.05, β= 0.8). Recruitment started in December 2024, and at the data cutoff, October 2025, 40 patients had been enrolled, of whom 13 initiated sasanlimab maintenance therapy."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Sasanlimab plus bacillus Calmette-Guérin in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Exploratory biomarker analysis of the phase 3 CREST trial. (ASCO-GU 2026) - P3 | "These findings demonstrate that pre-treatment NMIBC TMEs characterized by high immune infiltration are associated with poor outcomes with BCG monotherapy, potentially due to BCG promoting further upregulation of inhibitory molecules and adaptive immune resistance. The addition of sasanlimab to BCG-I-M may help overcome this resistance, offering a promising therapeutic strategy for pts with immune-infiltrated high-risk NMIBC. This combination has the potential to address a critical unmet need in the management of high-risk NMIBC, particularly within molecular subgroups associated with poor outcomes with BCG monotherapy."

Biomarker • IO biomarker • P3 data • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD8 • TMB

?HM-87884561: Sasanlimab Treatment As Bladder-Sparing Strategy For Patients With Muscle Invasive Bladder Cancer (clinicaltrialsregister.eu) - P1/2 | N=70 | Active, not recruiting | Sponsor: Fundacion De investigacion De Hm Hospitales | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SASANLIMAB IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) IN BCG-NAIVE, HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (NMIBC): EXPLORATORY ANALYSIS EVALUATING BCG-UNRESPONSIVE DISEASE (SUO 2025) - P3 | "This exploratory analysis shows that the addition of sasanlimab to BCG-I+M delays the development of BCG-unresponsive disease compared with BCG-I+M. These data suggest that this combined treatment can address a relevant unmet need for patients with BCG-naive high-risk NMIBC by delaying the administration of follow-up anticancer drug therapy for BCG-unresponsive disease, thereby reducing the treatment burden on these patients compared with BCG monotherapy."

Combination therapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Pfizer Europe MA EEIG withdrew its application for a marketing authorisation of Zumrad for the treatment of non-muscle invasive bladder cancer (NMIBC), a type of cancer that affects the lining of the bladder. (European Medicines Agency) - "The company withdrew the application on 13 February 2026."

European regulatory • Bladder Cancer

Treatment of non-muscle-invasive bladder cancer (PubMed, Urologie) - "The therapeutic landscape of NMIBC is undergoing rapid evolution. Combination strategies and novel intravesical therapies have the potential to expand the role of BCG to reduce recurrence and progression rates and further establish bladder-preserving treatment paradigms."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). (PubMed, J Immunother Cancer) - P1 | "PrCa VBIR overall demonstrated safety signals similar to other ICI combination trials; significant side effects were seen in some patients with BCR. It stimulated antigen-specific immunity across all cohorts and resulted in modest antitumor activity in patients with BCR without using ADT."

Journal • Metastases • P1 data • P1 data • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Immune Modulation • Infectious Disease • Influenza • Oncology • Prostate Cancer • Respiratory Diseases • Solid Tumor • PSCA

A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an in situ vaccine for cisplatin-ineligible muscle invasive bladder cancer (RAD VACCINE MIBC). (ASCO 2022) - P2 | "Exploratory endpoints include analysis of and association with pCR of the tumor/germline genetic signatures, circulating tumor DNA, tumor PD-L1 expression, blood cytometry time-of-flight analysis to identify immune response. Enrollment opened on February 15, 2022."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Inflammation • Oncology • Otorhinolaryngology • Pain • Solid Tumor • Urothelial Cancer

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=399 ➔ 9 | Trial completion date: Sep 2029 ➔ Apr 2026 | Trial primary completion date: Sep 2028 ➔ Mar 2026

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma. (PubMed, ESMO Open) - "Subcutaneous sasanlimab at 300 mg q4w was well tolerated with promising clinical efficacy observed. Phase II and III clinical trials of sasanlimab are ongoing to validate clinical benefit. Subcutaneous sasanlimab may be a potential treatment option for patients with NSCLC or urothelial carcinoma."

IO biomarker • Journal • Metastases • P1/2 data • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1 • TMB

Therapeutic Intensification Based on Immune Checkpoint Inhibitors in Non-Muscle Invasive Bladder Cancer: State of the Art and Future Perspectives. (PubMed, Cancers (Basel)) - "Therapeutic intensification using systemic immunotherapy applies to both BCG-unresponsive NMIBC, with a new target pathway (HLA-E/NKG2A), and BCG-naïve HR NMIBC, where the combination of BCG instillations and immunotherapy represents a major breakthrough."

Checkpoint inhibition • IO biomarker • Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HLA-E • KLRC1

Sasanlimab in combination with Bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (HR NMIBC): Asian subgroup analysis from CREST [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Combination therapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Sasanlimab in combination with Bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non-muscle-invasive bladder cancer (HR NMIBC): Exploratory analysis of patients with very HR (VHR) disease from the phase 3 CREST trial (EMUC 2025) - P3 | "Conclusions Sasanlimab with BCG-I+M outperformed BCG-I+M in the overall population and in subgroups of pts with CIS, T1, or VHR disease at randomization. Combined with a manageable safety profile, these data support the use of sasanlimab in combination with BCG as a potential practice-changing tx for pts with BCG-naive, HR NMIBC, including those with VHR disease."

Clinical • Combination therapy • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor