As a representative of immunotherapy drugs, PD-1 inhibitors have opened a new door for precision cancer treatment. 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: Hans-like®) independently developed by China Approved, this is the seventh PD-1 monoclonal antibody approved for marketing in China, and it is also the first domestic “pan-cancer” PD-1, which has fully opened a new era of domestic cancer treatment without limitation.
According to reports, slulimumab is mainly used for the treatment of unresectable, metastatic, highly microsatellite unstable (MSI-H) solid tumors.
Professor Qin Shukui, director of the Cancer Center of Nanjing Jinling Hospital, said that MSI-H/dMMR solid tumors are an A type of tumor that does not respond well to chemotherapy and molecularly 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. The approval of slulimumab for marketing is undoubtedly a brand new breakthrough.
Second, slulimumab, writing a new chapter in the treatment of MSI-H tumors
Slulimumab in China The first marketing application, based on a single-arm, open-label, multi-center Phase 2 clinical trial, aims 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, and 42 patients who paid special attention to efficacy analysis had an objective response rate (ORR) as high as 38.2%, of which 2 patients had complete remission; the 12-month survival (OS) rate of 68 patients in the primary 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 (range: 1.1–16.4) 16.4).
In the primary efficacy analysis population, the ORR assessed by IRRC was 38.2% (95% CI: 26.7, 50.8; 2 complete remissions, 24 partial responses); in the efficacy analysis population, the IRRC The estimated ORR was 31.0% (95% CI: 17.6%, 47.1%; 1 complete response, 12 partial responses).
It is understood that there are currently two PD-1 inhibitors with the same indications for solid tumors abroad, pembrolizumab and dostalimumab.
Among them, the data at the time of pembrolizumab’s approval was based on the overall response rate of 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 is completely comparable to the existing foreign PD-1 inhibitors .
2. High safety
According to Prof. During the clinical trial, the patients were generally well tolerated.
Safety results showed that the incidence of treatment-related adverse events (TRAEs) of grade ≥3 was 27.8% in the total enrollment population of 108 patients, and the incidence in the primary efficacy analysis population of 68 patients 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
Slulimumab is mainly aimed at treated, unresectable or Metastatic high microsatellite instability or mismatch repair deficient (MSI-H/dMMR) solid tumors, and MSI-H and dMMR are two common genetic abnormalities, and tumors with these abnormalities are widely distributed , can appear in the colorectum, endometrial, gastrointestinal tract, breast, prostate, bladder, thyroid and other parts. Therefore, distinguishing these cancers by the characteristics of genetic variation rather than the location of the disease 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.
In addition to the “pan-cancer species”, slulimumab has been approved for clinical trials in China, Europe and the United States and other countries, and has carried out a total of high-incidence cancers including hepatocellular carcinoma, esophageal cancer, lung cancer, head and neck cancer and gastric cancer. species of clinical trials.
According to relevant data, the number of newly diagnosed MSI-H tumor patients in China exceeds 300,000 each year. Currently, the domestic market targets advanced MSI-H solid tumors. PD-1 inhibitors are rare, and some patientsLack of effective treatment, 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.
References:
[1] “New Benchmark in Immunotherapy | PD-1 Inhibitor Slulimumab Approved for Marketing, Benefiting Chinese MSI-H Solid Tumor Patients” .China Medical Tribune Tumor Today.2022-03-25
[2] “Just now! Henlius’ “Slulimumab” Approved for Marketing”. Insight Database. 2022-03-24