Corbus Pharmaceuticals Announces FDA Clearance to Initiate TEMPO-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer
Rhea-AI Summary
Corbus Pharmaceuticals (NASDAQ: CRBP) reported that the U.S. FDA has cleared initiation of TEMPO-1, a registrational Phase 2 study of CRB-701, a next-generation Nectin-4–targeted antibody drug conjugate, in second-line oropharyngeal squamous cell carcinoma (OPSCC). The randomized controlled trial will enroll approximately 250 patients and compare CRB-701 to investigator’s choice of capecitabine, cetuximab or docetaxel. The primary endpoint is objective response rate to support a potential accelerated approval, with overall survival intended to support potential full approval. Corbus expects to begin enrollment in September 2026.
The FDA decision follows Phase 1/2 data in 2L+ OPSCC at a 3.6 mg/kg dose, where CRB-701 achieved a confirmed objective response rate of 42.9%, median duration of response of 6.3 months, and median progression-free survival of 5.6 months (ongoing). OPSCC is estimated to represent about half of U.S. second-line head and neck cancer cases, with roughly 14,000 patients annually eligible for 2L treatment and about 7,000 deaths. CRB-701 has two FDA Fast Track designations in head and neck squamous cell carcinoma and cervical cancer.
Positive
- FDA clearance to initiate TEMPO-1 registrational trial of CRB-701 in 2L OPSCC
- Phase 1/2 ORR 42.9% at 3.6 mg/kg in 2L+ OPSCC
- Median DoR 6.3 months and PFS 5.6 months in early OPSCC data (ongoing)
- Target U.S. population ~14,000 2L-eligible OPSCC patients annually
- Two FDA Fast Track designations for CRB-701 in HNSCC and cervical cancer
- TEMPO-1 sample size ~250 patients in randomized controlled design
Negative
- None.
News Explained
As of March 31, 2026, the FDA-cleared trial was authorized but not yet enrolled, while cash equaled 90.3 days of reported operating cash use.
The FDA has cleared Corbus to initiate TEMPO-1, but enrollment remains expected in
At
Sources and calculations
- Corbus Pharmaceuticals FDA clearance announcement (2026-07-28)
- Corbus Pharmaceuticals first-quarter fundamentals (2026Q1)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $25,661,000 / ($25,571,000 / 90) = [object Object]
News Market Reaction – CRBP
In the Jul 28 session, CRBP gained 0.06%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial,fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Sep 16 | Fast Track designation | Positive | +9.6% | FDA granted CRB-701 Fast Track status for head and neck squamous cell carcinoma |
| Dec 03 | Fast Track designation | Positive | -6.1% | FDA granted Fast Track status for CRB-701 in relapsed or refractory metastatic cervical cancer |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific FDA and clinical history was mixed: one announcement aligned with a positive reaction, while another diverged.
Key Terms
opscc medical
antibody drug conjugate medical
objective response rate medical
accelerated approval regulatory
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Company expects to initiate enrollment in TEMPO-1 in September 2026
- OPSCC is estimated to represent 1 in 2 head and neck cancer patients in the 2L setting in the U.S. with approximately 14,000 patients eligible annually for treatment
NORWOOD, Mass., July 28, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”) a clinical-stage company focusing on developing new therapies in oncology and obesity, today 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, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC).
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.
The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment and approximately 7,000 patients are estimated to succumb to the disease in the United States alone.
The FDA's decision to allow the registrational study to proceed was supported by results from Corbus' ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of
“The data presented at ASCO provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Unfortunately, current treatment options have shown limited efficacy underscoring the need for additional therapeutic options. OPSCC represents a significant commercial opportunity.”
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on developing new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act of 1995, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, anticipated timing for initiation of clinical trials, anticipated regulatory interactions and outcomes, including alignment with FDA on trial design, potential accelerated approval, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, sufficiency of cash runway and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
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INVESTOR CONTACTS:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
MEDIA CONTACT:
Liz Melone
Founder & Principal
Melone Communications, LLC
Liz@melonecomm.com
