sutantatug envedotin (CRB-701) / CSPC Pharma, Corbus Pharma - LARVOL DELTA

Evaluation of Nectin-4 protein expression and gene amplification in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with CRB-701 (SYS6002) during a phase 1/2 study (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Clinical • Metastases • P1/2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • NECTIN4

FIRST-IN-HUMAN STUDY OF SYS6002 IN PRETREATED ADVANCED CERVICAL CANCER (IGCS 2026) - P3 | "As of December 19, 2025, 91 cc patients (median age 53.0 year [range 29-80]; 92.3% distant metastases; 33.0% ≥3 prior therapy lines) received ≥1 dose of SYS6002. All patients had prior chemotherapy exposure. The RP2D in aCC pts was established as 2.4 mg/kg Q2W."

First-in-human • Metastases • P1 data • Cervical Cancer • Oncology • Solid Tumor

Association between human papillomavirus-driven tumor microenvironment biomarkers and anatomical subtypes in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with CRB-701 (SYS6002) during a phase 1/2 study (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Biomarker • Clinical • Metastases • P1/2 data • Tumor microenvironment • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A phase 1/2 study of the next-generation nectin-4–targeting antibody-drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer. (ASCO 2026) - P1/2 | "CRB-701 has shown promising efficacy in patients with R/M cervical cancer, as well as a favorable safety profile compared with other MMAE-based therapies. Ongoing evaluation of CRB-701 will determine its potential as a new treatment option for this patient population."

ADC • Clinical • Metastases • P1/2 data • Alopecia • Cervical Cancer • Head and Neck Cancer • Immunology • Keratitis • Ocular Inflammation • Oncology • Ophthalmology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • NECTIN4

Clinical update related to the first-in-human trial of SYS6002 (CRB-701), a next-generation nectin-4 targeting antibody drug conjugate. (ASCO 2024) - "No low-grade peripheral neuropathy, skin rash or fatigue, known toxicities that rate limit the usage of enfortumab vedotin (EV) have occurred. SYS6002 (CRB-701) demonstrates promising anti-tumor activity with a well-tolerated safety profile in patients with advanced nectin-4 positive solid tumors. Dose escalation at 4.5 mg/kg Q3W and dose expansion at 3.6 mg/kg Q3W are ongoing."

Clinical • P1 data • Cervical Cancer • Dermatology • Fatigue • Oncology • Pain • Solid Tumor • Urothelial Cancer • NECTIN4

CRB-701: a Second-Generation Nectin-4 Targeted Antibody-Drug Conjugate with Optimized Stability and Pharmacokinetics for the Treatment of Solid Tumors. (PubMed, Cancer Res Commun) - "The adhesion protein nectin-4 is a clinically validated tumor-selective antigen that is overexpressed across multiple cancer types and has been successfully exploited as a target for antibody-drug conjugates (ADCs), most notably enfortumab vedotin (EV), which is approved for treatment of urothelial carcinoma. CRB-701 delivered high levels of MMAE upon internalization in tumor cells and was markedly more stable in circulation than EV, with lower systemic MMAE release, an approximately two-fold longer half-life, and at least two-fold higher safety margin in monkeys. These results suggest that CRB-701 may be a promising alternative therapeutic for the treatment of nectin-4 expressing tumors, providing a more favorable therapeutic window and potentially enabling regimens with higher doses and less frequent dosing than are required for EV, the only currently approved nectin-4 targeting ADC."

Journal • PK/PD data • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer • NECTIN4

Corbus Pharmaceuticals Inc. is launching a Phase 3 study called “A Study to Evaluate CRB-701 Compared to Investigator’s Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma.” (The Globe and Mail)

Trial status • Oropharyngeal Cancer • Squamous Cell Carcinoma

TEMPO-1: A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=260 | Not yet recruiting | Sponsor: Corbus Pharmaceuticals Inc.

New P3 trial • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Holdings, Inc…announced that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study ('TEMPO-1') of CRB-701…in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC). (Corbus Pharmaceuticals Press Release) - "Company expects to initiate enrollment in TEMPO-1 in September 2026...TEMPO-1 is a randomized controlled study (n=250) designed to evaluate the efficacy and safety of CRB-701 compared with investigator’s choice of capecitabine, cetuximab or docetaxel. The study's primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval."

IND • Oropharyngeal Cancer • Squamous Cell Carcinoma of Head and Neck

A phase 1/2 study of the next-generation nectin-4–targeting antibody-drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma. (ASCO 2026) - P1/2 | "CRB-701 has shown promising efficacy in patients with heavily pretreated R/M HNSCC, along with a favorable safety profile compared with other MMAE-based therapies. Further investigation of CRB-701 is warranted in this difficult-to-treat patient population."

ADC • Clinical • IO biomarker • Metastases • P1/2 data • Alopecia • Cervical Cancer • Head and Neck Cancer • Immunology • Keratitis • Ocular Inflammation • Oncology • Ophthalmology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • NECTIN4

A phase 1b study of SYS6002 in advanced solid tumors. (ASCO 2026) - P1 | "SYS6002 demonstrated a distinct safety profile from other Nectin-4 ADCs. Its promising efficacy in aUC patients, extending to those progressing on prior MMAE-based ADCs, supports further phase 3 trials."

Metastases • P1 data • Dry Eye Disease • Oncology • Ophthalmology • Solid Tumor • Steven-Johnson Syndrome • Urothelial Cancer • NECTIN4

Corbus Pharmaceuticals Reports Updated CRB-701 Phase 1/2 Clinical Data Demonstrating Robust Activity in 2L Oropharyngeal and Cervical Cancers (Corbus Pharmaceuticals Press Release) - "Confirmed ORR of 42.9% observed in 2L oropharyngeal squamous cell carcinoma (OPSCC) at 3.6 mg/kg with median DOR of 6.3 months and PFS of 5.6 months (ongoing), Confirmed ORR of 34.4% observed in 2L cervical cancer at 3.6 mg/kg with median DOR of 8.0 months and PFS of 4.3 months (ongoing)...Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC ('TEMPO-1') in the summer of 2026. Broad alignment was reached with the U.S. Food and Drug Administration (FDA) on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator’s choice of monotherapy with overall response rate (ORR) as the primary endpoint for potential accelerated approval and potential full approval based on overall survival (OS) benefit. Similarly, broad alignment was reached with the FDA regarding the trial design for a randomized controlled study of CRB-701 in 2L cervical cancer."

New trial • P1/2 data • Cervical Cancer • Oropharyngeal Cancer • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals...announced that the Company’s management team will host a conference call and webcast on Tuesday, May 26 at 8:00 a.m. EDT to discuss updated data for its Phase 1/2 study of CRB-701, a next-generation Nectin-4 antibody drug candidate (ADC), in both head and neck squamous cell carcinoma (HNSCC) as well as cervical cancer. (Corbus Pharmaceuticals Press Release) - "The data, which will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, represent an April 1, 2026 data cut, and will include clinical response durability data as well as HNSCC patient subgroup analysis...Corbus will host an in-person and virtual KOL event during the 2026 ASCO to discuss the updated data from the Phase 1/2 clinical study of CRB-701 in 75 participants with HNSCC."

P1/2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck

Reached broad alignment with the FDA on the registration path for CRB-701 for 2L treatment in head and neck squamous cell carcinoma (HNSCC) and cervical cancer with CRB-701 (The Manila Times) - "Announced presentation of updated CRB-701 data in HNSCC and cervical cancer at ASCO 2026; Initiate a registrational study for CRB-701 in second-line HNSCC this summer. Report CRB-701 + Keytruda combination data in first-line HNSCC patients in early Q1 2027 to support potential further registration-enabling trials."

New trial • P1/2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Holdings, Inc…announced that it will host an in-person and virtual KOL event at the 2026 American Society of Clinical Oncology (ASCO) annual meeting to discuss updated data from the Phase 1/2 clinical study of CRB-701 in 75 participants with head and neck squamous cell carcinoma (HNSCC). (The Manila Times) - "Data will include clinical response durability as well as HNSCC patient subgroup analysis."

P1/2 data • Squamous Cell Carcinoma of Head and Neck

First-in-human study of SYS6002 in pretreated advanced cervical cancer (aCC) (ESMO-Gynae 2026) - No abstract available

First-in-human • Metastases • P1 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Corbus Pharmaceuticals Holdings, Inc…announced that updated clinical data from its Phase 1/2 study of CRB-701…in both head and neck squamous cell carcinoma (HNSCC) and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 – June 2 in Chicago, IL. (Corbus Pharmaceuticals Press Release) - "The data will include clinical response durability as well as HNSCC patient subgroup analysis."

P1/2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck

SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=406 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Oncology • Solid Tumor • Urothelial Cancer

Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer (Corbus Pharmaceuticals Press Release) - "The agreed upon second-line registrational study designs for CRB-701 include: HNSCC: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice chemotherapy with potential accelerated approval using objective response rate (ORR) as the primary endpoint and potential full approval granted on overall survival (OS) benefit; Cervical cancer: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice of chemotherapy or Tivdak with potential accelerated approval using ORR as the primary endpoint and potential full approval granted on OS benefit; Continued interactions with the FDA planned to finalize the protocols and statistical analysis plans for the registrational studies."

FDA event • New trial • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck

Updated clinical data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 29 – June 2 in Chicago. Data will include clinical response durability as well as HNSCC patient subgroup analysis. (Corbus Pharmaceuticals Press Release) - "The company also anticipates reporting data with CRB-701 in combination with Keytruda in first-line HNSCC patients in Q4 2026 to support potential further registration-enabling trials...'We look forward to sharing updated monotherapy data on CRB-701 at ASCO and expect to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026'..."

New trial • P1/2 data • Squamous Cell Carcinoma of Head and Neck

Anticipated catalysts for CRB-701 in 2026 (Corbus Pharmaceuticals Press Release) - "Provide update in Q1 2026 from discussions with FDA regarding registrational study protocols for HNSCC and cervical cancer. Report monotherapy data in mid-2026 with a key focus being durability data and patient stratification. Generate CRB-701 + Keytruda combination data in first line (“1L”) HNSCC patients in Q4 2026."

FDA event • P1/2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Touts “Catalyst-Rich” 2026 With CRB-701…Data Readouts Ahead (MarketBeat) - "Corbus outlined a 'catalyst-rich' 2026 with mid-year and late-year data readouts planned for its two clinical programs and said FDA discussions for second-line cervical and head‑and‑neck programs are expected in Q1 2026."

FDA event • P1/2 data • Cervical Cancer • Head and Neck Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=444 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1/2 trial • Solid Tumor

SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=412 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Cervical Cancer • Oncology • Solid Tumor