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Junshi’s domestic Toripalimab’s significant results in recurrent or metastatic HNSCC. CRL issued on Nasopharyngeal Carcinoma could prove to be a setback?

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ASCO 2022: Junshi’s domestic Toripalimab’s Highlight

Toripalimab and cetuximab in combination have shown preliminary safety and efficacy in treating platinum-resistant recurrent or metastatic head and neck squamous cell carcinoma.

Inhibitory mechanism of toripalimab: Programmed cell death-1 receptor antagonists, antibody-dependent cell cytotoxicity, and T lymphocyte stimulants. Angiogenesis inhibitors, antibody-dependent cell cytotoxicity, and antagonists of the epidermal growth factor receptors make up Cetuximab's mode of action.

A recombinant humanised anti-PD-1 monoclonal antibody for injection that targets various malignant tumours is called toripalimab. Based on Phase I/II clinical trials, the company disclosed its preliminary findings about the safety of toripalimab plus cetuximab.

Junshi Biosciences displayed their pipeline in ASCO 2022 on June 6, 2022. Preliminary findings of toripalimab combined with cetuximab in platinum-refractory recurrent or metastatic HNSCC were provided by the company. After a median follow-up time of 6.9 months, the medication was found to be well-tolerated, with an objective response rate (ORR) of 50% and a disease control rate (DCR) of 100%.

According to the company's earlier abstract, which had a cutoff date of December 2021, no dose-limiting toxicities (DLT) were noted during this trial, and roughly 76.9% of patients had TRAEs.The investigation is currently moving on to the next phase.

Phase II trial is ongoing; additional assessments are necessary to comprehend how well the medication works to treat platinum-refractory cancer.

KOL insights:

“Even though the drug has obtained various designations from the US FDA for different indications, the recent negative FDA response on the Nasopharyngeal Carcinoma can impact the future of this drug. If approved, the drug will be very beneficial for these patients in this group. At the same time ,its journey will be easy for the approval of other indications, including HNSCC.”– Expert Opinion.


Squamous cell carcinomas of the Head and Neck Cancer (HNSCC) are the most prevalent kinds of head and neck cancer. The management of head and neck cancer is quite difficult. The effectiveness of the already authorised drugs is insufficient. More therapeutic options with improved response rates and outcomes than current medicines are needed for patients with recurrent and metastatic HNSCC.

Toripalimab is the first local anti-PD-1 monoclonal antibody to receive approval for sale in China. Toripalimab received Breakthrough Therapy Designation from the US FDA in September 2020 to treat recurrent/metastatic nasopharyngeal cancer. The drug that was being studied for patients with metastatic nasopharyngeal cancer and as a monotherapy in the second-line or later treatment of patients with recurrent or metastatic disease after platinum-containing chemotherapy recently encountered a setback from the US FDA, and they issued a complete response letter stating to change their quality process. The business intends to resubmit the application for a biologics licence (BLA).

Further evaluation of the medication's safety and effectiveness will shed further light on its potential to treat platinum-refractory patients with recurrent or metastatic head and neck squamous cell carcinoma.

Companies- Immutep, Bristol Myers Squibb, F-star Therapeutics, Checkmate Pharmaceuticals, Oncosec Medical Incorporated, Nanobiotix, Jiangsu Hengrui Pharmaceutical/Luzsana Biotechnology; Exelixis; CEL-SCI; Shanghai Junshi Bioscience; MacroGenics; Chia Tai Tianqing Pharmaceutical Group; PDS Biotechnology, and others.

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