Corbus Pharmaceuticals Announces First Patient Dosed in TEMPO-1 Registrational Study of CRB-701 in Patients with 2L+ Oropharyngeal Cancer
The controlled study compares CRB-701 with existing treatment choices to gather evidence for potential approval.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Corbus Pharmaceuticals (CRBP) dosed the first patient in its TEMPO-1 registrational study of CRB-701 for previously treated oropharyngeal cancer. The randomized, controlled study is designed for 250 patients with second-line or later oropharyngeal squamous cell carcinoma. It compares CRB-701 with an investigator’s choice of capecitabine, cetuximab or docetaxel. Objective response rate, a measure of tumor shrinkage, is the primary endpoint intended to support potential accelerated approval; overall survival is intended to support potential full approval.
The FDA allowed TEMPO-1 to proceed based on results from an ongoing Phase 1/2 study. Among patients with second-line or later disease treated at the 3.6 mg/kg dose, CRB-701 produced a confirmed objective response rate of 42.9%, median response duration of 6.3 months and median progression-free survival of 5.6 months (ongoing).
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFirst patient dosed in TEMPO-1, a registrational study designed for 250 patients.
- Moderate pointFDA approval to proceed with TEMPO-1 was supported by ongoing Phase 1/2 results.
- Moderate point42.9% confirmed objective response rate in second-line or later patients treated at 3.6 mg/kg in the Phase 1/2 study.
- Minor pointMedian response duration was 6.3 months in that Phase 1/2 patient analysis.
- Minor pointMedian progression-free survival was 5.6 months (ongoing) in that Phase 1/2 patient analysis.
- Minor pointTwo FDA Fast Track designations cover CRB-701 in head and neck squamous cell carcinoma and cervical cancer.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.Accelerated and full approval remain potential; TEMPO-1’s response and survival endpoints are intended to support them, respectively.
Key Figures
- Study enrollment
- 250 patients
- Randomized TEMPO-1 study
- Confirmed ORR
- 42.9%
- Phase 1/2 analysis of 2L+ OPSCC patients treated at 3.6 mg/kg
- Median duration of response
- 6.3 months
- Phase 1/2 analysis of 2L+ OPSCC patients treated at 3.6 mg/kg
- Median progression-free survival
- 5.6 months
- Phase 1/2 analysis of 2L+ OPSCC patients treated at 3.6 mg/kg; ongoing
Historical Context
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FDA cleared TEMPO-1, with 250-patient enrollment expected to begin in September
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
antibody drug conjugate medical
objective response rate medical
overall survival medical
accelerated approval regulatory
progression-free survival medical
duration of response medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection
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 for treatment annually
NORWOOD, Mass., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on new therapies in oncology and obesity, today announced that the first patient has been dosed in its TEMPO-1 registrational study of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line and beyond (2L+) oropharyngeal squamous cell carcinoma (OPSCC).
“For patients with recurrent or metastatic head and neck cancer, there remains a significant unmet need for new treatment options after progression on frontline therapy,” said Dr. Cesar A. Perez, Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists & Research Institute in Orlando, FL, and Principal Investigator of the TEMPO-1 study. “The current standard options have been largely unchanged since the introduction of PD-1 inhibitors nearly a decade ago. We are proud that SCRI at Florida Cancer Specialists & Research Institute is helping evaluate a potential new therapeutic approach through the TEMPO-1 study.”
HPV infection is driving the rise of both the incidence and prevalence of OPSCC in the U.S. 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 die from the disease in the U.S. alone.
“Dosing the first patient in our TEMPO-1 trial marks an important step in advancing CRB-701 as a potentially novel targeted therapeutic for those impacted by OPSCC,” said Leonardo Nicacio, M.D., Chief Medical Officer of Corbus Pharmaceuticals. “Based on the Phase 1/2 data we presented at ASCO 2026, we believe that CRB-701 has the potential to deliver meaningful clinical benefit with a manageable safety profile in this underserved patient population. We are excited to be underway with TEMPO-1, which is designed to generate the evidence needed to support a potential regulatory submission.”
Study Design
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.
FDA approval for the TEMPO-1 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
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 focusing on 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. There can be no assurance that TEMPO-1 will achieve its primary or secondary endpoints, that CRB-701 will receive accelerated or full approval from the FDA, or that previously reported clinical data will be replicated in larger controlled studies.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission including those described in our Annual Report on Form 10-K for the year ended December 31, 2025, and other filings we make with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
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
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is Corbus Pharmaceuticals testing in the TEMPO-1 study of CRB-701?
TEMPO-1 is a randomized, controlled study designed for 250 patients with second-line or later oropharyngeal squamous cell carcinoma. It compares CRB-701 with an investigator’s choice of capecitabine, cetuximab or docetaxel.
What did Corbus Pharmaceuticals report from its earlier CRB-701 study in oropharyngeal cancer?
In an ongoing Phase 1/2 study, patients with second-line or later disease treated at 3.6 mg/kg had a confirmed objective response rate of 42.9%. Median response duration was 6.3 months, and median progression-free survival was 5.6 months (ongoing).