Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11

Rhea-AI Summary

Shanghai Henlius Biotech and Organon (NYSE: OGN) have announced that their phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) biosimilar HLX11 has met its primary endpoint. The study compared HLX11 with reference Perjeta® as a neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer.

The trial (NCT05346224) was a multicenter, randomized, double-blind, parallel-controlled study. Patients received either HLX11 or reference Perjeta® combined with trastuzumab and docetaxel. The primary endpoint was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee. Secondary endpoints included various response rates, survival measures, safety, pharmacokinetics, and immunogenicity.

In 2022, Henlius granted Organon exclusive global commercialization rights for HLX11, except for China. Pertuzumab is approved in various countries for neoadjuvant, first-line, and adjuvant treatment of certain advanced HER2-positive breast cancers.

Positive

• Phase 3 clinical trial for Perjeta® biosimilar HLX11 met its primary endpoint
• Potential expansion of Organon's product portfolio in the oncology market
• Global commercialization rights secured by Organon, except for China

Negative

• None.

Insights

Oncology Research Analyst

The successful phase 3 trial of HLX11, a biosimilar to Perjeta® (pertuzumab), is a significant development in the breast cancer treatment landscape. Meeting the primary endpoint of total pathological complete response (tpCR) rate suggests comparable efficacy to the reference drug. This could potentially lead to a more cost-effective treatment option for HER2-positive breast cancer patients. The study's focus on neoadjuvant therapy for early or locally advanced breast cancer is particularly noteworthy, as it addresses a critical stage in treatment. The global commercialization rights held by Organon (except for China) position the company to potentially capture a share of the lucrative biosimilar market. However, it's important to note that secondary endpoints are still being analyzed and regulatory approval processes will follow. The impact on Organon's revenue stream will depend on pricing strategies, market acceptance and the competitive landscape for HER2-targeted therapies.

Pharmaceutical Market Strategist

This development represents a strategic win for both Henlius and Organon. By successfully demonstrating biosimilarity to Perjeta®, a blockbuster drug, they've positioned themselves to tap into a high-value market. Biosimilars typically offer 15-30% cost savings compared to reference products, which could drive adoption, especially in price-sensitive markets. For Organon, this aligns with their strategy to expand their portfolio in women's health and biosimilars. The global rights (excluding China) provide a broad market opportunity. However, the timing of market entry is crucial, as competition in the biosimilar space is intensifying. The success of HLX11 could potentially impact Roche's Perjeta® sales, which reached 3.7 billion Swiss francs in 2022. Investors should watch for regulatory submissions, potential approval timelines and Organon's commercialization strategy, including pricing and market access plans, to gauge the potential revenue impact.

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta^® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon.

The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study (NCT05346224) aimed to compare the efficacy and safety of HLX11 with reference Perjeta^® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta^® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by Independent Review Committee (IRC). The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), safety, pharmacokinetics, and immunogenicity. The primary endpoint of this study was met.

Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant, first-line, and adjuvant treatment for certain advanced HER2-positive breast cancer.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has proactively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding the business plans of Organon and Henlius. Forward-looking statements may be identified by words such as “pursuing,” “opportunities,” “vision,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

View source version on businesswire.com: https://www.businesswire.com/news/home/20240930000839/en/

Organon Media:

Karissa Peer

(614) 314-8094



Hannah Silver

(917) 509-8864



Organon Investor:

Jennifer Halchak

(201) 275-2711



Henlius Media:

Bella Zhou

wenting_zhou@henlius.com



Janice Han

jiayi_han@henlius.com

 

Source: Organon & Co.

FAQ

What was the primary endpoint of the HLX11 phase 3 trial for Organon (OGN)?

The primary endpoint of the HLX11 phase 3 trial was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee (IRC).

What type of cancer is HLX11 being studied for by Organon (OGN)?

HLX11 is being studied as a neoadjuvant therapy for HER2-positive, HR-negative early or locally advanced breast cancer.

When did Organon (OGN) acquire the rights for HLX11?

Organon acquired the exclusive global commercialization rights for HLX11, except for China, in 2022 through a license and supply agreement with Henlius.

What other treatments were used in combination with HLX11 in the Organon (OGN) phase 3 trial?

In the phase 3 trial, HLX11 was used in combination with trastuzumab and docetaxel as part of a complete treatment regimen.