sasanlimab (PF-06801591) / Pfizer - LARVOL DELTA

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

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

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

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 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

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

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

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 | "Clinical Trial Registry Number: NCT06623162. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • 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 | "Clinical Trial Registry Number: NCT04165317. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Biomarker • P3 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 | "Clinical Trial Registry Number: NCT05241340. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • 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 (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

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

Bladder Cancer

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

A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines. (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; Study terminated as part of strategic considerations and not based on safety concerns.

First-in-human • Trial termination • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Combination Approaches With Systemic Immunotherapy Enhance Medical Oncologists’ Role in NMIBC (Targeted Oncology) - "'However, overall survival was not improved, and in the prespecified subgroup analysis, it appears that patients who had CIS benefited more,' Gupta said."

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CREST Physician Experience Survey: Evaluating the Impact of Time and Effort of Treatment Administration in Non-Muscle Invasive Bladder Cancer (NMIBC) (ISPOR-EU 2025) - P3 | "Despite small sample, findings suggest that among specialists, urologists lead diagnosis and treatment selection in HR-NIMBC. Pending approval, SC sasanlimab may offer a quicker, more convenient treatment option, potentially saving time, effort, and resource costs for healthcare systems."

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

NKT2152-202: Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov) - P2 | N=18 | Terminated | Sponsor: NiKang Therapeutics, Inc. | N=172 ➔ 18 | Trial completion date: Jun 2026 ➔ Sep 2025 | Active, not recruiting ➔ Terminated; This study was terminated as a result of Sponsor portfolio reprioritization.

Enrollment change • Trial completion date • Trial termination • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Nephrology • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor • Urethral Cancer • Urology

Re: Sasanlimab plus BCG in BCG-naive, High-risk Non-muscle Invasive Bladder Cancer: The Randomized Phase 3 CREST Trial. (PubMed, Eur Urol) - No abstract available

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

A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer (clinicaltrials.gov) - P1 | N=294 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

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

RAD-VACCINE: Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: The Methodist Hospital Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Apr 2027

Enrollment closed • Trial completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer