As a representative of immunotherapy drugs, PD-1 inhibitors have opened a new door for the precise treatment of cancer. PD-1 drugs are currently one of the most successful therapies in tumor immunotherapy, leading the revolution in cancer treatment. Cancer cells die by blocking the PD-1/PD-L1 signaling pathway.

In recent years, research on domestic PD-1 inhibitors is also developing rapidly, and self-developed immunotherapy drugs have given patients more choices. And recently, the good news came again.

1. Good news! The first domestic “pan-cancer species” PD-1-slulimumab is on the market!

On March 24, 2022, the innovative PD-1 drug slulimumab (H drug, serplulimab, HLX10, trade name: Hansezoid®) independently developed by China was approved by This is the seventh PD-1 monoclonal antibody approved for marketing in China, and it is also the first domestically produced “pan-cancer” PD-1, which fully opens the door to unlimited cancer types in China A new era of therapy.

According to reports, slulimumab is mainly used for the treatment of unresectable, metastatic high-grade microsatellite instability type (MSI-H) solid tumors.

Professor Qin Shukui, Director of Nanjing Jinling Hospital Cancer Center

span> indicated that MSI-H/dMMR solid tumors are a class of tumors that have poor response to traditional chemotherapy and molecular targeted therapy. Although the proportion of this type of patients in the overall tumor population is not high, the more common ones are colorectal cancer, accounting for about 10%-15%, while only about 5% in advanced colorectal cancer, and only about 1%-2% in other tumors. %. But this part of the population is special and more sensitive to immunotherapy.

Clinical trials in Europe and the United States have shown that PD-1 inhibitors are more effective for such tumors and can significantly improve the prognosis of patients. Therefore, China has also begun to carry out related explorations. And the approval of slulimumab is undoubtedly a brand new breakthrough.

Second, slulimumab, writing a new chapter in the treatment of MSI-H tumors

The first domestic launch of slulimumab The application is based on a single-arm, open-label, multicenter Phase 2 clinical trial to evaluate the efficacy, safety and tolerability of slulimumab in the corresponding patient population.

According to clinical data, slulimumab has the characteristics of good efficacy, high safety, and pan-cancer indications.

1. Good curative effect

A total of 108 patients were included in this clinical study, 42 The objective response rate (ORR) of the population with special attention to the efficacy analysis was as high as 38.2%, of which 2 patients had complete response; the 12-month survival (OS) rate of the 68 patients in the main efficacy analysis population was 81.2%.

Specifically, the median follow-up time for the primary efficacy analysis population was 7.7 months (range: 1.1–16.4), and the median follow-up time for the special efficacy analysis population was 7.3 months months (range: 1.1–16.4).

In the primary efficacy analysis population, the IRRC-assessed ORR was 38.2% (95% CI: 26.7, 50.8; 2 complete responses, 24 partial responses); special attention In the efficacy analysis population, the IRRC-assessed ORR was 31.0% (95% CI: 17.6%, 47.1%; 1 complete response, 12 partial response).

It is understood that there are currently two PD-1 inhibitors with the same indications for solid tumors abroad, pembrolizumab and dostalimumab.

Among them, pembrolizumab was approved based on the data that the overall response rate was 39.6%, of which 78% of patients had a response that lasted for more than 6 months. Dostalimumab was approved on the basis of an excellent response rate of 41.6% in patients with solid tumors with dMMR, including a complete response rate of over 9%.

It can be seen that,Comparing the two FDA-approved drugs, the data of slulimumab is not inferior, and the efficacy It is completely comparable to the existing PD-1 inhibitors abroad.

2, high security< /strong>

According to Prof. Qin Shukui, the drug was generally well tolerated by patients during the clinical trial.

Safety results showed that the incidence of treatment-related adverse events (TRAEs) of grade ≥3 was 27.8% in the total enrolled population of 108, and in 68 major patients. The incidence in the efficacy analysis population was 32.4%; the incidence of adverse events leading to drug discontinuation was only 5.6% in the overall population and 4.4% in the primary analysis population. It can be seen that the safety factor of slulimumab is relatively high.

3. Pan-cancer indications

Slullimumab is mainly aimed at of treated, unresectable or metastatic high-grade microsatellite instability or mismatch repair deficient (MSI-H/dMMR) solid tumors, and MSI-H and dMMR are two common genetic Abnormalities, tumors with these abnormalities are widely distributed and can appear in multiple parts such as colorectum, endometrium, gastrointestinal tract, breast, prostate, bladder, and thyroid. Therefore, distinguishing these cancers by genetic variation characteristics rather than disease location has certain guiding significance for clinical treatment.

According to reports, slulimumab has shown good safety and tolerability in standard treatment, and is expected to improve the clinical efficacy of patients. p>

In addition to the “pan-cancer species”, slulimumab has been approved for clinical trials in China, Europe and the United States and other countries. Cancer clinical trials.

According to relevant data, the number of new MSI-H tumor patients in China exceeds 300,000. At present, PD-1 inhibitors for MSI-H advanced solid tumors are relatively rare in the domestic market. Some patients lack effective treatment, and the clinical treatment needs are far from being met. The approval of slulimumab injection is expected to fill this gap in demand, benefit patients and bring new hope for survival.

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