Positive Topline Results Reported from Bristol Myers Squibb's Phase 3 CheckMate-67T Trial of Subcutaneous Nivolumab with Halozyme's ENHANZE® Drug Delivery Technology for Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Rhea-AI Summary

Bristol Myers Squibb (BMS) reports positive results from Phase 3 trial of subcutaneous nivolumab in renal cell carcinoma

Positive

• The Phase 3 trial of subcutaneous nivolumab with ENHANZE showed positive topline results
• The study met its co-primary pharmacokinetics endpoints and key secondary endpoint
• Subcutaneous nivolumab demonstrated noninferiority compared to intravenous Opdivo in terms of objective response rate
• The safety profile of subcutaneous nivolumab was consistent with intravenous Opdivo

Negative

• None.

BMS in discussions with health authorities regarding next steps for submission and approval of subcutaneous nivolumab in multiple indications

SAN DIEGO, Oct. 19, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Bristol Myers Squibb (BMS) reported positive topline results from the Phase 3 CheckMate-67T trial evaluating a subcutaneous (SC) formulation of Opdivo (nivolumab) with ENHANZE® in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The study met its co-primary pharmacokinetics endpoints and key secondary endpoint.

CheckMate-67T Data Highlights

• Co-primary endpoints met; the study demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous (IV) Opdivo.
• Subcutaneous nivolumab showed noninferiority of objective response rate (ORR) by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint.
• The safety profile of SC nivolumab was consistent with IV Opdivo.

"We are pleased that the positive topline results from BMS' trial of subcutaneous nivolumab with ENHANZE support a shorter treatment time, as a single injection administered in less than five minutes, potentially making it a more convenient treatment option for patients," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This is the fifth positive phase 3 data readout from our Wave 3 products in the last 19 months, supporting the high success rate in the translation of phase 1/2 ENHANZE SC pharmacokinetic data into positive phase 3 data." 

BMS will share detailed results from the CheckMate-67T trial at an upcoming medical meeting and work with health authorities on next steps for SC nivolumab across multiple indications.

About CheckMate-67T

CheckMate-67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme's proprietary recombinant human hyaluronidase rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial include time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in five commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED® and TLANDO® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE® drug delivery technology including the possible benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery of injectable medications through subcutaneous delivery and certain other potential benefits of ENHANZE® including lowering the treatment burden for patients. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth and expansion of our collaboration opportunities driven by our partners' development and commercialization efforts (including anticipated discussions with healthcare regulatory authorities regarding subcutaneous nivolumab). These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered products (including subcutaneous nivolumab), regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.  Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contacts

Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com

Dawn Schottlandt 
Argot Partners
212-600-1902
Halozyme@argotpartners.com

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What were the results of the Phase 3 CheckMate-67T trial?

The study met its co-primary pharmacokinetics endpoints and key secondary endpoint, demonstrating positive results for subcutaneous nivolumab with ENHANZE in renal cell carcinoma.

How does subcutaneous nivolumab compare to intravenous Opdivo?

Subcutaneous nivolumab showed noninferiority to intravenous Opdivo in terms of objective response rate.

What is the safety profile of subcutaneous nivolumab?

The safety profile of subcutaneous nivolumab was consistent with intravenous Opdivo.

What are the next steps for subcutaneous nivolumab?

BMS will share detailed results at an upcoming medical meeting and work with health authorities on next steps for subcutaneous nivolumab across multiple indications.