Zumrad (sasanlimab) / Pfizer - LARVOL DELTA

Response-adapted bladder-sparing strategy with sasanlimab after neoadjuvant chemotherapy in muscle-invasive bladder cancer: Phase II SASAN-SPARING trial (NCT06623162) (ESMO 2026) - P2 | No abstract available

Clinical • P2 data • 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

Immune checkpoint inhibition plus Bacillus Calmette-Guerin (BCG) therapy in BCG-naive high-risk non-muscle-invasive bladder cancer: a critical review in the context of current evidence (PubMed, Urologie) - "Combination therapy strictly necessitates the full BCG maintenance schedule. Given the significant systemic toxicity and the current lack of a demonstrated overall survival benefit, careful patient selection is mandatory."

Checkpoint inhibition • Journal • Review • 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

A Phase 1 Study of PF-07062119, an Anti-GUCY2C/Anti-CD3 Bispecific Fc Antibody, in Patients With Advanced Gastrointestinal Cancers. (PubMed, Cancer Res Commun) - P1 | "PF-07062119 monotherapy demonstrated a generally tolerable safety profile within the context of this early-phase study with evidence of clinical activity in patients with advanced/metastatic gastrointestinal cancers."

First-in-human • Journal • P1 data • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Oncology • Solid Tumor • GUCY2C

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

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

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 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

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

Population Pharmacokinetics and Exposure-Response of Sasanlimab, a Checkpoint Inhibitor, in Patients with Non-Muscle Invasive Bladder Cancer and Other Solid Tumors. (PubMed, J Clin Pharmacol) - "For efficacy, no association was found between exposure and the key endpoints: investigator-assessed event free survival and complete response (in participants with carcinoma in situ). In total, the popPK results and absence of ER associations for safety and efficacy endpoints support the recommended flat dose of sasanlimab 300 mg SC Q4W."

Checkpoint inhibition • Journal • PK/PD 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): 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

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

THE GAIN TRIAL: Gemcitabine Alternating with INtravesical BCG randomized against BCG alone for patients with recurrent "BCG-exposed" high grade NMIBC (ALLIANCE A032303/ NCT07000084) (AUA 2026) - P1/2, P3 | "gemcitabine plus docetaxel) or TAR-200.Any prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, sasanlimab, durvalumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc.) are all allowed...Notable exclusion criteria include current/prior MIBC and prior intolerance to BCG or any other intravesical therapy. Other notable aspects of the trial include: (1) the reduced burden on investigators & research teams due to the NCI's new streamlined data initiative, (2) pragmatic inclusion/exclusion criteria and pragmatic design to improve generalizability of results, and (3) cystoscopic biopsies/TURBT at week 13/month 3 for all participants (both CIS & "papillary only") for multiple reasons including to allow for earlier..."

Clinical • IO biomarker • Bladder Cancer • Prostate Cancer • Urothelial Cancer

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

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 single arm phase 2 study of sasanlimab, palbociclib and axitinib in metastatic renal cell carcinoma - SPARCC. (EIKCS 2026) - P2 | "In preclinical studies, CDK4/6 inhibitors have shown in vitro activity against ccRCC and tRCC5 while combination with a VEGFR-TKI (abemaciclib with sunitinib) led to tumor reduction in murine xenografts5. The study will employ a single-arm one stage design with planned sample size of 25 patients. The study began enrollment in multiple sites across the United States beginning December 2025."

IO biomarker • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CDKN2A • TFE3 • VHL

SPARCC: A Single Arm Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma (NCT07123090) (KCRS 2026) - P2 | "In preclinical studies, CDK4/6 inhibitors have shown in vitro activity against ccRCC and tRCC while combination with a VEGFR-TKI (abemaciclib with sunitinib) led to tumor reduction in murine xenografts. The study will inform the use of CDK4/6 inhibitors and expand therapeutic strategies in first line treatment of RCC beyond PD-1/ VEGF-TKI combination treatments. Conclusions N/A Keywords Renal cell carcinoma, tRCC, sasanlimab, palbociclib, axitinib, CDK4/6 DOD CDMRP Funding yes"

IO biomarker • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CDKN2A • TFE3 • VHL

A PHASE II PROSPECTIVE, OPEN-LABEL, MULTI-CENTER, SINGLEARM STUDY OF SASANLIMAB PLUS SACITUZUMAB GOVITECANIN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS. SSANTROP (APRO07-2022) (AUA 2024) - "Based on Keynote-057 (complete response (CR)rate 41%), pembrolizumab has been recently approved by the FDAfor the treatment of NMIBC BCG-unresponsive patients who areineligible for or decline cystectomy. No safety concerns have been initially reported. This trial would be the first to systematically address whethercombining sasanlimab plus SG improves CR rates in patients withBCG-unresponsive NMIBC."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • Urothelial Cancer

SPARCC: A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Stephanie Berg | Trial primary completion date: Oct 2026 ➔ Oct 2027

Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • TFE3 • TFEB

A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation. (clinicaltrials.gov) - P1 | N=330 | Recruiting | Sponsor: Pfizer | Trial completion date: Sep 2028 ➔ Jan 2029 | Trial primary completion date: Sep 2027 ➔ Jan 2028

IO biomarker • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • KRAS • ROS1

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=30 | Terminated | Sponsor: Pfizer | Not yet recruiting ➔ Terminated; The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.

IO biomarker • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • ROS1

Network meta-analysis of immune checkpoint inhibitors in BCG-naïve, high-risk non-muscle-invasive bladder cancer. (PubMed, Urol Oncol) - "In this NMA, durvalumab plus BCG and sasanlimab plus BCG significantly reduced events vs. BCG alone (HR 0.68 each), whereas atezolizumab plus BCG did not (HR 0.98; 95% CI 0.71-1.36). Pairwise indirect comparisons between active regimens were not statistically significant; point estimates and P-scores are consistent with a 2-tier efficacy pattern but do not establish between-agent differences. CIS-stratified subgroup analyses are exploratory and require confirmation."

Checkpoint inhibition • Journal • Retrospective data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=0 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | N=24 ➔ 0

Enrollment change • Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • PD-L1 • ROS1

SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov) - P1 | N=397 | Recruiting | Sponsor: Seagen Inc. | Trial completion date: Mar 2023 ➔ Apr 2025 | Trial primary completion date: Dec 2022 ➔ Jan 2025

Metastases • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peripheral T-cell Lymphoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • Urothelial Cancer • TIGIT