Junshi Biological released the first-line Phase III study data of Teriprizumab in the World Lung Cancer Conference (WCLC) for the first-line treatment of non-small cell lung cancer

From September 8th to 14th, 2021, the annual academic event in the field of lung cancer - the 22nd World Conference on Lung Cancer (WCLC) was held in the form of a virtual meeting.
Junshi Bio-Treprizumab will bring three latest studies The results were unveiled
.
Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences issued an oral presentation (Mini Oral, number: MA13.

The results of the first phase III study of lung cancer announced, which can simultaneously treat patients with NSCLC squamous cell carcinoma and non-squamous cell carcinoma

Lung cancer is currently the world’s second most common malignant tumor with the second highest mortality rate [1]
.
According to data released by the World Health Organization, the number of lung cancer cases in China in 2020 accounted for 17.

The CHOICE-01 study is the first large-scale, randomized, double-blind, large-scale, randomized, double-blind, first-line treatment to include both advanced squamous cell carcinoma and non-squamous cell carcinoma NSCLC patients in the same study in China.
Placebo parallel controlled, multi-center phase III clinical study (NCT03856411)
.
The results of the interim analysis published on the WCLC of the CHOICE-01 study are also the first key registered clinical data of Teriplizumab in the field of lung cancer

The CHOICE-01 study included a total of 465 patients with newly-treated advanced NSCLC without EGFR/ALK driver gene mutations, including 220 patients with squamous cell carcinoma (47%) and 245 patients with non-squamous cell carcinoma (53%).
More than 80% of the patients were in He was diagnosed as stage IV when he joined the study without medication
.
As of November 17, 2020, the median PFS of the teriprizumab combined chemotherapy group (n=309) and the placebo combined chemotherapy group (n=156) were 8.

At the same time, as of March 2021, OS data is still immature, but a survival benefit trend has been observed in the triprolizumab group.
The median OS is estimated to be 21.
0 months vs.
16.
0 months
.

In terms of anti-tumor activity, the objective response rate (ORR) of the teriprizumab group and the placebo group was 63.
4% vs.
41.
7% (p<0.
0001), and the duration of response (DoR) was 8.
3 months vs.
4.
2 Months
.
In terms of safety, the most common adverse events (TEAEs) during treatment were mostly grade 1 to 2.

"Compared with chemotherapy alone, the addition of teriprizumab to the treatment of advanced NSCLC with first-line chemotherapy has shown better PFS, higher ORR and longer DoR, and a clear trend of OS benefit has been observed.
We look forward to follow-up data that will provide stronger evidence for teriprizumab combined with chemotherapy as a first-line treatment option for NSCLC
.
” said Professor Wang Jie, the main investigator of the CHOICE-01 study, “I am more gratified that CHOICE- 01 From design to implementation of research, the research and development team embodies the maximum protection and respect for the interests of patients

The research and development team pioneered the use of albumin paclitaxel as a control protocol in patients with squamous cell carcinoma.

Dr.
Patricia Keegan, Chief Medical Officer of Junshi Biotech, said: “CHOICE-01 is the first study to publish data in the 4 key lung cancer registration clinical trials of
Teriplimumab.
The performance in the field of lung cancer is a good start

The final analysis of the PFS of the CHOICE-01 study and further OS analysis will be carried out later this year
.
Junshi Bio and its partner Coherus plan to discuss with the U.
S.
Food and Drug Administration to advance the marketing application for related indications
.

Teriplizumab's exploration in the field of NSCLC neoadjuvant therapy and pulmonary sarcomatoid carcinoma is expected

PD-1/PD-L1 inhibitors as a neoadjuvant therapy show good anti-tumor activity in patients with stage IB-IIIA non-small cell lung cancer (NSCLC)
.
The team of Professor Yang Nong and Professor Zhang Yongchang from Hunan Cancer Hospital conducted a phase II single-arm trial to explore the use of teriprizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment for potentially resectable IIIA-IIIB Anti-tumor activity, safety and feasibility in NSCLC patients (NCT04144608)
.
Preliminary research results showed good clinical efficacy and tolerability.
The R0 resection rate reached 83.
3% (15/18), the major pathological response rate (MPR) was 53.
3%, and the pathological complete response rate (pCR) was 40.
0%, which is expected to change It is a treatment strategy for such patients
.

The research results were presented in a poster (number: P15.
02) at the current WCLC, which further enriched the evidence-based medicine evidence of teriprizumab in the field of neoadjuvant therapy for NSCLC
.
At present, teriplizumab has taken the lead in deploying a series of perioperative adjuvant/neoadjuvant treatment research for multiple tumor types including lung cancer, and its progress is at the forefront in China
.

Another poster (number: P14.
06) of Teriplizumab showed the design of an open, multi-center, single-arm Phase II clinical trial (NCT04725448) carried out by Professor Li Juan's team from Sichuan Cancer Hospital
.
The purpose of this study is to evaluate the effectiveness and safety of teriprizumab combined with bevacizumab and platinum-containing chemotherapy in newly treated patients with advanced pulmonary sarcomatoid carcinoma (PSC)
.
PSC is a rare type of NSCLC.
The best clinical treatment strategy is not yet clear, but its tumor mutational burden (TMB) is higher.
Compared with other types of NSCLC, the expression of PD-L1 is more common, indicating that immunotherapy may be possible.
The treatment of PSC is promising, and the breakthrough of Tereprizumab in various subdivisions of NSCLC is worth looking forward to
.