ASCO 2022: Junshi’s domestic Toripalimab’s Highlight

Shanghai reports preliminary safety and efficacy data of toripalimab in combination with cetuximab in platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma.

Toripalimab mechanism of action: Antibody-dependent cell cytotoxicity; Programmed cell death-1 receptor antagonists; T lymphocyte stimulants

Cetuximab mechanism of action: Angiogenesis inhibitors; Antibody-dependent cell cytotoxicity; Epidermal growth factor receptor antagonists

Toripalimab is a recombinant humanized anti-PD-1 monoclonal antibody for injection addressing various malignant tumors. The company reported its preliminary results related to the safety of toripalimab combined with cetuximab based on Phase I/II clinical trials.

On 6th June 2022, Junshi Biosciences highlighted its pipeline in ASCO 2022. The company presented the preliminary results of toripalimab in combination with cetuximab in platinum-refractory recurrent or metastatic HNSCC. The drug was found to be well-tolerated, with an objective response rate (ORR) of 50% and a disease control rate (DCR) of 100%, and this data was achieved after a median follow-up period of 6.9 months.

As per the abstract submitted previously by the company, where the cutoff date was December 2021, no dose-limiting toxicities (DLT) were observed during this trial, and approximately 76.9% of patients experienced TRAEs.

The next portion of the study is ongoing. The Phase II trial is underway; further evaluations will be required to understand the drug’s performance in treating platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma.

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.


Head and neck squamous cell carcinomas (HNSCC) are the most common head and neck cancer types. Treatment of head and neck cancer is quite challenging. The existing approved medications have limited efficacy. For patients with recurrent and metastatic HNSCC, more treatment alternatives with better response rates and outcomes than existing therapies are required.

In the China market, toripalimab is the first approved domestic anti-PD-1 monoclonal antibody. In September 2020, toripalimab was granted Breakthrough Therapy Designation by the US FDA to treat recurrent/metastatic nasopharyngeal carcinoma. Recently the drug which was being investigated for patients with metastatic nasopharyngeal carcinoma and as a monotherapy in the second-line or later treatment of recurrent or metastatic patients after platinum-containing chemotherapy faced a setback from the US FDA, and a complete response letter was issued by them stating to alter their quality process.  The company is planning to resubmit the biologics license application  (BLA).

Further safety and efficacy analysis of the drug will provide more clarity on its ability to treat recurrent or metastatic head and neck squamous cell carcinoma in platinum-refractory patients.

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