As previously reported at the 2023
In October, Coherus and Junshi announced the
'There are limited options for patients living with this aggressive head and neck cancer. New treatment options are desperately needed for underserved cancer patients particularly ones with rare cancers,' said
'The final OS data published in JAMA demonstrates the potential of LOQTORZI to significantly extend survival while slowing the progression of NPC, an aggressive form of cancer which up until now has had no approved therapies and therefore represents an important unmet need for patients in the US living with NPC,' said
Titled Toripalimab plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma, the paper highlights the addition of LOQTORZI to gemcitabine-cisplatin (GP) chemotherapy as first-line treatment for patients with recurrent or metastatic NPC provided superior OS compared to GP alone [HR=0.63 (95% CI: 0.45-0.89), two-sided p=0.008]. The median OS was not reached in the LOQTORZI arm and was 33.7 months in the placebo arm. The 2-year and 3-year OS rates were 78.0% vs. 65.1%, and 64.5% vs. 49.2% respectively. A consistent effect on OS, favoring the LOQTORZI arm, was observed in the majority of the subgroups, including PD-L1 expression and EBV copy number high and low subgroups. The addition of LOQTORZI to chemotherapy also provided superior progression-free survival (PFS) compared to chemotherapy alone, with a median PFS of 21.4 vs. 8.2 months [HR=0.52 (95% CI: 0.37, 0.73)]. The safety profile was consistent with that previously reported in other toripalimab clinical trials and consistent with the PD-1 inhibitor class. The full results can be found in the online edition of JAMA.
'From the oral presentation at the ASCO Annual meeting's Plenary Session, to the cover article of Nature Medicine, and now publication in JAMA, the survival benefits of JUPITER-02 have become increasingly evident, gradually establishing the status of toripalimab plus chemotherapy as the first-line standard treatment for advanced NPC. We are extremely proud to contribute to the international advancement of the clinical diagnosis and treatment of NPC,' said Professor
'Toripalimab in combination with chemotherapy is the world's first and only first-line treatment for recurrent/metastatic NPC to achieve both statistically and clinically significant OS benefits in a Phase 3 study,' said Dr.
About NPC
NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of the skull. NPC is rare in
Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Patients treated with chemotherapy alone experience poor prognosis: only 20% experience one-year PFS; up to 50% developed distant metastasis during their disease course and low median OS of 29 months.
LOQTORZI is the first FDA-approved therapy for NPC and will represent a new standard of care for treating the disease when used in combination with cisplatin and gemcitabine in the first line setting or as monotherapy in the second line or greater setting.
About LOQTORZI (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.
About
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus' immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.
Coherus' earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with LOQTORZI in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.
Coherus markets UDENYCA (pegfilgrastim-cbqv), a biosimilar of Neulasta, CIMERLI (ranibizumab-eqrn), a biosimilar of Lucentis, YUSIMRY (adalimumab-aqvh), a biosimilar of Humira and expects to launch LOQTORZI (toripalimab-tpzi), a novel next generation PD-1 inhibitor, in the
About Junshi Biosciences
Founded in
With a mission of 'providing patients with world-class, trustworthy, affordable, and innovative drugs', Junshi Biosciences is 'In
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus' ability to find synergies between its I-O pipeline and its commercial operations; expectations for the launch date of LOQTORZI and expectations that treatment with LOQTORZI in combination with chemotherapy will become the new standard-of-care for patients with NPC.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to realizing the anticipated benefits of the acquisition of Surface; risks related to Coherus' existing and potential collaboration partners; risks of Coherus' competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus' business and the timing of Coherus' regulatory filings; the risk of FDA review issues; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' products and product candidates and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements.
UDENYCA, CIMERLI YUSIMRY and LOQTORZI whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.
Contact:
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