2022 Milestone Clinical Research TOP10

Let the years go by and the world go through vicissitudes, and 2022 will finally become a thing of the past. This year, we have experienced many difficulties, but we have also ushered in the key results of some blockbuster clinical research, including new breakthroughs that reshape clinical treatment methods, breakthroughs in innovative therapies, or key research that supports drug marketing. Here, the Rubik's Cube Med team once again selects the breakthrough or "landmark" clinical research results that will be disclosed in 2022 and support the launch of transformative therapies for your reference.

NO.1 DurvalumabТОПАЗ-1

Исследованияfirm: AstraZeneca

Clinical significance: the first immunotherapy for biliary tract cancer, a new standard of first-line treatment

In January 2022, a phase III study of durvalumab combined with chemotherapy in patients with advanced biliary system tumors without systemic treatment was announced at the 2022 American Society of Clinical Oncology Symposium on Gastrointestinal Cancers (ASCO GI) (TOPAZ-1) data. The results showed that the risk of death in the durvalumab plus chemotherapy group was 20% lower than chemotherapy alone. At 18 months of follow-up, the overall survival rate in the durvalumab-combined group was 35.1%, compared with 25.6% in the chemotherapy-alone group. At 2 years of follow-up, the overall survival rates of the two groups were 24.9% and 10.4%, respectively.

Specifically, compared with placebo, the progression-free survival and overall survival of the durvalumab combination group were significantly improved, 7.2 months vs 5.7 months, respectively (HR, 0.75; 95% CI 0.63-0.89 ; P = 0.001), the median OS of the two groups was 12.8 months and 11.5 months, respectively. Immunotherapy also improved the objective response rate (ORR), which was 26.7% and 18.7% in the two groups, respectively; but the disease control rates were similar in the two groups, 85.3% and 82.6%, respectively; the median response time was also similar, respectively 6.4 months and 6.2 months.

In September 2022, based on the research results of TOPAZ-1, the FDA took the lead in approving durvalumab combined with chemotherapy for the first-line treatment of cholangiocarcinoma. However, even if approved by regulatory agencies and included in clinical guidelines, durvalumab combined with chemotherapy still faces many problems and challenges in cholangiocarcinoma. A hepatobiliary surgeon from a tertiary hospital in China believes that although the TOPAZ-1 study is enough to change the guidelines, it will become the standard first-line treatment for advanced biliary system tumors. However, efficacy data were somewhat disappointing, with a median OS extension of only 1.3 months. Although the benefit of patients further increased as time went on; but if you look carefully at the survival curve, the difference between the two groups appeared slowly after 6 months.

In addition, there are some differences between the design of TOPAZ-1 study and clinical practice. In this study, the control group stopped the drug directly after 8 cycles of GC chemotherapy, which is not completely consistent with clinical practice.

NO.2 NivolumabCheckMate-816

Исследованияfirm: Bristol-Myers Squibb

Clinical significance: the first immune neoadjuvant therapy for lung cancer

CheckMate-816 is the first phase III clinical study to demonstrate that immune-based combination therapy can significantly improve EFS and pathological complete response (pCR) rate in patients with non-small cell lung cancer in the neoadjuvant stage. In April 2022, the EFS data of the CheckMate-816 study was announced for the first time at the annual meeting of the American Association for Cancer Research (AACR) and simultaneously published in the New England Journal of Medicine.

CheckMate-816 is a randomized, open-label, multicenter phase III clinical trial designed to evaluate nivolumab (Opdivo, nivolumab) in combination with chemotherapy as neoadjuvant therapy in patients with resectable IB compared with chemotherapy alone. Efficacy in stage to IIIA NSCLC patients, the primary endpoints of the study are EFS (event-free survival) and pCR (pathological complete response rate). In the primary analysis, 358 patients were randomized to receive nivolumab (360 mg) plus platinum-based doublet chemotherapy (every 3 weeks for a maximum of 3 cycles) based on histological type or platinum-based chemotherapy alone before surgery. Double-drug chemotherapy (once every 3 weeks, up to 3 cycles).

The EFS data published for the first time showed that patients who received nivolumab combined with chemotherapy before surgery had a 37% lower risk of disease recurrence, progression or death (HR 0.63, p=0.0052), and the median EFS was 31.6 months, and the median EFS in the platinum doublet chemotherapy group was 20.8 months.

In March 2022, the FDA approved nivolumab combined with chemotherapy for the neoadjuvant treatment of adult patients with resectable (tumor ≥ 4 cm or positive lymph nodes) non-small cell lung cancer (NSCLC). Nivolumab is the first neoadjuvant immunotherapy in the field of lung cancer, and it is also the only immune neoadjuvant therapy in lung cancer so far. It has also allowed immunotherapy to complete the full line of neoadjuvant, adjuvant, first-line and above multi-course treatments in the field of lung cancer Qualification layout.

NO.3 TrastuzumabСУДЬБА-грудь04

Исследованияcompany: AstraZeneca/Daiichi Sankyo

Clinical significance: the first HER2 low expression targeted therapy

In June 2022, Dr. Shanu Modi from Memorial Sloan Kettering Cancer Center reported the latest data of DESTINY-Breast04 at the American Society of Clinical Oncology (ASCO) meeting. DESTINY-Breast04 study is the first randomized phase III clinical trial for patients with metastatic breast cancer with low expression of HER2. Patients with low expression of HER2, unresectable, and/or metastatic breast cancer were included, and patients with metastatic status had received 1-2 lines of chemotherapy; HR+ patients were endocrine refractory patients, who were randomly divided into two groups according to 2:1, divided into Dequ Tocilizumab (Enhertu, T-DXd) group and physician's choice treatment (TPC) group. The primary endpoint is PFS (HR+) in BICR (blinded independent central assessment); secondary endpoints include: PFS in BICR (all patients), OS (HR+ patients, all patients).

The results showed that in the HR+ population, the PFS of the T-DXd group and the TPC group were 10.1 months and 5.4 months, respectively (HR=0.51, P<0.0001); in the total population, the PFS of the T-DXd group and the TPC group were respectively 9.9 months and 5.1 months (HR=0.50, P<0.0001). In terms of OS, in the HR+ population, the OS of the T-DXd group and the TPC group were 23.9 months and 17.5 months, respectively (HR=0.64, P=0.0028); in the total population, the OS of the T-DXd group and the TPC group were 23.4 months vs. 16.8 months (HR=0.64, P=0.0010).

In addition, in the HR-population, the PFS of the T-DXd group and the TPC group were 8.5 months and 2.9 months (HR=0.46); the OS of the T-DXd group and the TPC group were 18.2 months and 8.3 months, respectively (HR=0.48). At the same time, ORR data also has significant advantages in both HR+ and HR- populations. Overall, the DESTINY-Breast04 study met its primary and secondary endpoints, with benefit seen in all subgroups. Due to the success of the DESTINY-Breast04 study, detrastuzumab will be approved by the FDA for the treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer in August 2022. adult patients.

The success of the DESTINY-Breast04 study brought the first HER2 low-expression breast cancer therapy, and also challenged the treatment model, classification and markers of breast cancer. Of course, it is also possible that the level of HER2 expression required for T-DXd to exert therapeutic activity is lower than the detection sensitivity of current IHC, and there are new requirements for how to evaluate HER2 status with more accurate and sensitive methods. However, with the DAISY study, T-DXd also had an objective response rate (ORR) performance of nearly 30% for HER2-negative (IHC 0) patients, which may also cause rethinking of the concept of ADC drugs.

In addition, based on the DESTINY-Lung01 study, detrastuzumab was approved in August 2022 for previously treated advanced NSCLC with HER2 activating mutations, becoming the only HER2-targeted drug approved so far in the field of lung cancer. The treatment method fills the drug gap in HER2-mutated NSCLC.

NO.4 KarXT in the treatment of schizophreniaEMERGENT-2

ИсследованияCompany: Karuna Therapeutics

Clinical significance: The first new drug for schizophrenia in 50 years is expected to come out

In August 2022, Karuna Therapeutics announced that its drug KarXT (xanomeline-trospium) for the treatment of adult schizophrenia had achieved the primary endpoint in the clinical phase III EMERGENT-2 trial. Karuna plans to submit a New Drug Application (NDA) to the FDA in mid-2023, making it potentially the first new class of drug to treat schizophrenia in 50 years.

KarXT (xanomeline-trospium) is an oral M1/M4 muscarinic agonist consisting of the muscarinic agonist xanomeline and the muscarinic antagonist trospium, designed to preferentially stimulate muscarinic receptors in the central nervous system, Relieves negative symptoms such as apathy, reduced social drives, improves cognition and is helpful in improving other psychiatric symptoms such as hallucinations and delusions. The quaternary ammonium salt compound trospium chloride is a muscarinic receptor antagonist, which can inhibit the side effects of xanomeline in peripheral nerves. KarXT is in development for the treatment of psychiatric and neurological disorders, including schizophrenia and psychosis in Alzheimer's disease, and has the potential to be the first novel dual-mechanism drug that does not target dopaminergic and serotonergic pathways drug.

The EMERGENT-2 trial is a double-blind, placebo-controlled, five-week Phase III clinical study evaluating the efficacy, safety and tolerability status of KarXT compared with placebo in adults with schizophrenia in the United States. The primary endpoint was the change from baseline in the KarXT Positive and Negative Syndrome Scale (PANSS) total score (a scale that measures the severity of symptoms in schizophrenia) compared with placebo at week 5. The results showed that, compared with the placebo, after 5 weeks, the total score of the positive and negative symptom scale in the KarXT group was significantly reduced by 9.6 points compared with the baseline (p<0.0001). The study also met key secondary endpoints, showing statistically significant reductions in both positive and negative symptoms of schizophrenia as measured by the PANSS-positive, PANSS-negative and PANSS-negative Marder factor subscales.

Steve Paul, MD, CEO, President and Chairman of Karuna Therapeutics, noted that the EMERGENT-2 study is the second time KarXT has achieved positive registration trial results to support the submission of KarXT's new drug application to the FDA for the treatment of schizophrenia in mid-2023 The plan strengthens KarXT's new and unique mechanism and may bring the first drug with a new mechanism of action to schizophrenia patients in more than 50 years.

NO.5 Aprocitentan for the treatment of resistant hypertensionТОЧНОСТЬ

Исследованияfirm: Idorsia/Actelion Pharma

Clinical significance: It is expected to create the first innovative high blood pressure drug in 30 years

In May 2022, Idorsia announced positive top-line results from the PRECISION study. PRECISION is a phase III study investigating Idorsia's dual endothelin receptor antagonist aprocitentan in patients receiving at least triple antihypertensive therapy but whose blood pressure remains inadequately controlled (known as resistant hypertension).

In the world, there are about 1.3 billion hypertensive patients, and 10% of them, that is, more than 100 million patients, are resistant hypertensive patients, that is, despite receiving at least 3 different types of antihypertensive drugs, blood pressure Still out of control. The endothelin pathway is implicated in the pathogenesis of hypertension, and endothelin-1 (ET-1) is a potent vasoconstrictor that also induces neurohormonal activation, vascular hypertrophy and remodeling, cardiac hypertrophy and fibrosis, and endothelial function obstacle. In hypertension, both ETA and ETB receptors mediate the deleterious effects of ET-1.

Aprocitentan, as a novel oral dual endothelin receptor antagonist, is the active metabolite of macitentan, has a longer half-life (48 vs 14 hours) and a higher accumulation index, and can effectively inhibit ET-1 and ETA Binding to ETB receptors. The PRECISION trial was a multicenter, blinded, randomized, parallel-group controlled phase III study conducted at hospitals or research centers in Europe, North America, Asia, and Australia. Included patients had received standardized background therapy consisting of three antihypertensive medications, including diuretics, but had a systolic blood pressure of 140 mm Hg or higher. The study consisted of three consecutive parts: Part 1 was a 4-week double-blind, randomized and placebo-controlled part in which 730 patients were randomized 1:1:1 to aprocitentan 12.5 mg (n=243), 25 mg (n=243) or placebo (n=244); part 2 was a 32-week single (patient) blinded part in which all patients received 25 mg of aprocitentan (n=704); part 2 Part 3 was a 12-week double-blind, randomized, and placebo-controlled withdrawal portion in which patients were re-randomized 1:1 to aprocitentan 25 mg (n=307) or placebo (n=307). The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from off-drug baseline to week 40, respectively. Secondary endpoints included 24-hour ambulatory blood pressure change.

Results showed that compared with placebo, aprocitentan reduced blood pressure at week 4 of treatment, the effect was maintained and confirmed through week 48, and was generally well tolerated. Specifically, office systolic blood pressure decreased by 15.3 mmHg, 15.2 mmHg and 11.5 mmHg from baseline in the aprocitentan 12.5 mg group, 25 mg group and placebo group at 4 weeks; The systolic blood pressure in the two groups decreased significantly, which were 3.8 mmHg (95%CI: -6.8～-0.8; P＝0.0042) and 3.7 mmHg (95%CI: -6.7～-0.8; P＝0.0046); The blood pressure decreased by 4.2 mmHg (95%CI: -6.2～-2.1) and 5.9 mmHg (95%CI: -7.9～-3.8) respectively. After 4 weeks of withdrawal, office systolic blood pressure was significantly higher in the placebo group (5.8 mmHg, 95% CI: 3.7-7.9, P<0.0001). In conclusion, the study achieved statistically significant and clinically meaningful results for both the primary and key secondary endpoints

In November 2022, the full results of the PRECISION study will be published in The Lancet and presented as the latest Breakthrough Science presentation at the 2022 American Heart Association (AHA) Scientific Sessions. In December, Idorsia announced the completion of the New Drug Application (NDA) submitted to the FDA for aprocitentan for the treatment of patients with resistant hypertension. If approved, the drug could become the first blood pressure-lowering drug based on a new mechanism in 30 years, according to the release.

NO.6 AXS-05 in the treatment of Alzheimer's disease agitation ACCORD

Исследованияfirm: Axsome

Clinical significance: It is expected to promote the launch of the first Alzheimer's disease agitation drug

In November 2022, Axsome announced the key data of the phase III clinical trial ACCORD (NCT04797715) of AXS-05 (dextromethorphan + bupropion) in the treatment of Alzheimer's disease agitation. ACCORD is a phase III, randomized, double-blind, placebo-controlled, multicenter trial of 178 patients diagnosed with suspected Alzheimer's disease and clinically significant agitation associated with other diseases. Subjects first received AXS-05 treatment in an open-label format for 9 weeks, and 108 patients who showed sustained clinical response then entered the double-blind phase in a 1:1 ratio to receive AXS-05 (n=53) or placebo (n=55) and the test was stopped when the agitation recurred or after 26 weeks of treatment. Sustained clinical response was defined as a &ge;30% improvement in the Cohen-Mansfield Agitation Inventory (CMAI) score and PGI-C (score &le;3) maintained for at least 4 consecutive weeks. Agitation relapse was defined as a &ge;10-point deterioration in the CMAI total score after randomization or a higher CMAI total score than baseline; or hospitalization for Alzheimer's disease-related agitation. The primary endpoint of the trial was the time to relapse of Alzheimer's disease agitation assessed by Kaplan-Meier and hazard ratio, and the key secondary endpoint was the percentage of patients who relapsed.

The results showed that AXS-05 significantly delayed the recurrence of agitation symptoms compared with placebo, the hazard ratio was 0.275 (p=0.014), and the risk of agitation recurrence was reduced by 3.6 times, and the trial reached the primary endpoint. The trial also met the key secondary endpoint of a significant reduction in relapse of agitation symptoms during the double-blind treatment period: AXS-05 vs placebo relapse rate was 7.5% vs 25.9% (p=0.018). In addition, in the first week of treatment in the open-label phase, patients can quickly observe a significant improvement in the total score of CMAI (p<0.001), and reduce 11.0 points compared with baseline in the second week (p<0.001). Weekly reduction of 20.6 points (p <0.001). Clinicians also reported rapid and substantial improvement in AD agitation, with 66.3% of patients improving at week 2 and 86.3% at week 2 following AXS-05 treatment on the mADCS-CGIC scale. 5 weeks improved. The PGI-C scale showed that agitation improved in 67.5% and 89.3% of patients at week 2 of AXS-05 treatment.

In 2022, the phase III trial GEMINI (NCT04019704) data will be updated again, and AXS-05 will show a rapid, definite and statistically significant improvement in depressive symptoms and induced remission compared with placebo, and the change in MADRS score at week 6 compared with baseline More significantly (-15.9 vs -12.0, p=0.002). In August, AXS-05 (AUVELITY, dextromethorphan + bupropion) sustained-release tablet was approved by FDA for the treatment of severe depression, and AXS-05 became the first and only one approved for severe depression At the same time, AXS-05 is the first oral antidepressant with a new mechanism of action in the past 60 years.

NO.7 Gepotidacin in the treatment of female adults and adolescents with simple urinary tract infection EAGLE-2 and EAGLE-3

Исследованияfirm: GSK

Clinical significance: the first innovative oral antibiotic for uncomplicated urinary tract infection in 20 years

In November 2022, GSK announced that following the recommendation of the Independent Data Monitoring Committee (IDMC), two pivotal Phase III trials of gepotidacin in female adults and adolescents, EAGLE-2 (NCT04020341) and EAGLE- Patient recruitment for 3 (NCT04187144). The decision was based on a prespecified interim efficacy and safety data analysis of 3,000 patients who achieved clinical and microbiological co-remissions with gepotidacin compared with nitrofurantoin in two similar phase III trials, EAGLE-2 and EAGLE-3 primary efficacy endpoint.

Uncomplicated urinary tract infection (uUTI) is the most common outpatient infection, with more than half of women developing a uUTI in their lifetime and more than a quarter of women having a recurrent uUTI. The EAGLE Phase III program includes three clinical trials: EAGLE-2 and 3 are similar trials that together will provide a substantial body of clinical evidence. Both EAGLE-2 and EAGLE-3 are non-inferiority uUTI trials, mainly comparing the effectiveness and Safety, the trial lasted about 28 days. The primary clinical endpoint was the combined clinical and microbiological response rate among patients with eligible uropathogens at TOC follow-up.

The final follow-up and data collection of EAGLE-2 and EAGLE-3 will be completed in the first quarter of 2023, and GSK will also submit a regulatory application for gepotidacin to the regulatory agency in the first half of 2023. Gepotidacin is a new type II topoisomerase inhibitor of triazaacenaphthylenes, which is different from quinolone antibiotics. Gepotidacin acts by inhibiting the binding mode of DNA gyrase and topoisomerase IV, and has a broad-spectrum antibacterial effect active.

Currently, there has been no new oral antibiotic for the treatment of uncomplicated urinary tract infection (uUTI) in 20 years, and gepotidacin is expected to become the first new oral antibiotic for the treatment of uUTI in 20 years.

NO.8 Tirzepatidefor treating obesity SURMOUNT-1

Исследованияfirm: Eli Lilly

Clinical significance: the first drug to reduce body weight by more than 20% on average in phase III clinical trials

In April 2022, Lilly announced key data from the phase III SURMOUNT-1 (NCT04184622) trial of tirzepatide in the treatment of obesity. The SURMOUNT-1 study, the first global phase III registration study of tirzepatide in obese patients, enrolled 2539 patients with at least one comorbidity (hypertension, dyslipidemia, obstructive sleep apnea syndrome or cardiovascular disease) , but not with diabetes mellitus) in obese or overweight patients, to assess the efficacy and safety of tirzepatide in combination with placebo in addition to a low-calorie diet and increased exercise.

The subjects were divided into 1:1:1:1 groups, the initial dose of tirzepatide was 2.5 mg once a week, and then the treatment dose was increased to the target dose of 5 mg, 10 mg, and 15 mg by 2.5 mg every 4 weeks. And maintain treatment to 72 weeks. The composite end point of the study setting is that the percentage effect of tirzepatide10mg and 15mg dose groups on reducing body weight at week 72 and the proportion of patients who lost more than 5% of weight are superior to the placebo control group.

The results of the study showed that the mean body weight reduction from baseline was 16.0% vs 21.4% vs 22.5% vs 2.4% for 5mg tirzepatide vs 10mg tirzepatide vs 15mg tirzepatide vs placebo. In addition, the proportion of patients who lost more than 5% of their body weight was 89% vs 96% vs 96% vs 28%. The proportion of patients with a weight loss of more than 20% was 55% (10mg) vs 63% (15mg) vs 1.3%, meeting the dual primary and key secondary endpoints.

Tirzepatide, the first FDA-approved GIP/GLP-1 receptor agonist, was compared with various positive drugs (including semaglutide, dulaglutide, insulin glargine, and insulin degludec) in the phase III SURPASS trial , have achieved a better effect of reducing HbA1c. The SURMOUNT-1 study once again made tirzepatide the first drug to reduce body weight by an average of more than 20% in Phase III clinical trials. Lilly plans to start rolling weight loss applications in 2022 and launch the SURMOUNT-2 trial around April 2023 The Phase 3 data is submitted shortly after completion of the application.

NO.9 DCVax-Lin the treatment of newly diagnosed or recurrent glioblastoma phase III

Исследованияfirm: Northwest

Clinical implications: first immunotherapy for glioblastoma

In November, Northwest Biotherapeutics (NW Bio) announced that its phase III study of dendritic cell therapy DCVax-L in the treatment of patients with newly diagnosed or recurrent glioblastoma (nGBM/rGBM) reached the primary endpoint, that is, significantly prolonging the median survival time of patients. The survival period and the "long tail" of the survival curve were published simultaneously in the journal "JAMA Oncology".

Glioblastoma (GBM) is the most common and deadly primary brain cancer, with a recurrence rate of nearly 100%. GBM patients usually relapse within 6-8 months after initial surgery, and the average survival rate of patients after diagnosis is only 15-17 months, and the 5-year survival rate is only 5.7%. The study (NCT00045968) spanned more than 20 years and enrolled a total of 331 patients, who were divided into two cohorts, DCVax-L group (n=232) and placebo group (n=99), of which 64 patients in the placebo group had relapsed Received DCVax-L treatment. The originally scheduled primary endpoint was progression-free survival (PFS), but NW Bio believed that this indicator was not sufficient to measure efficacy, and later redefined the indicator as overall survival (OS) in nGBM patients, and the secondary endpoint was OS in rGBM patients.

The results showed that in the nGBM cohort (n=232), the median OS of patients in the DCVax-L group was 19.3 months (22.4 months after surgery) and 16.5 months in the control group (HR=0.80, p=0.002) . In addition, the 48-month survival rates of DCVax-L and control patients were 15.7% and 9.9%, respectively, and 13% and 5.7% at 60 months, respectively.

In the rGBM cohort (n=64), the median OS of patients in the DCVax-L group was 13.2 months, compared with 7.8 months in the control group (HR=0.58, p<0.001). In addition, the 24-month survival rates of DCVax-L and control patients were 20.7% and 9.6%, respectively, and 11.1% and 5.1% at 30 months.

In more than 400 clinical trials since 2005, with more than 32,000 patients testing different treatment modalities, only one phase III trial of nGBM demonstrated a survival benefit, and none of the phase III studies in the field of rGBM obtained8 Survival benefits. DCVax-L is the first dendritic cell vaccine to announce the results of phase III study, and it is also the first phase III study to prove that immunotherapy can successfully prolong the survival of nGBM patients in the past 20 years, and it is also the first to significantly prolong the survival of rGBM patients in the past 30 years Phase III study.

NO.10Tumor vaccinemRNA-4157 combined with pembrolizumabin the treatment of melanoma KEYNOTE-942/mRNA-4157-P201

Testcompany: Moderna/ Merck

Clinical implications: first randomized clinical demonstration of mRNA efficacy in cancer therapy

In December 2022, Moderna and Merck announced the key results of the phase IIb KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 combined with pembrolizumab in the adjuvant treatment of patients with stage III/IV melanoma after complete resection , the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) compared to pembrolizumab monotherapy.

mRNA-4157/V940 is a novel investigational personalized cancer vaccine based on messenger ribonucleic acid (mRNA), consisting of a single synthetic mRNA encoding up to 34 neoantigens based on the DNA unique to each patient's tumor Sequence mutation signatures are designed by algorithms.

KEYNOTE-942/mRNA-4157-P201 is an open-label phase IIb trial, a total of 157 patients were enrolled and were randomly assigned to receive mRNA-4157/V940 (9 doses every 3 weeks) and pembrolizumab alone Antibiotic (200 mg every 3 weeks) combination therapy, or pembrolizumab alone. The primary endpoint was recurrence-free survival, and secondary endpoints included distant metastasis-free survival and overall survival. Data analysis showed that, compared with pembrolizumab monotherapy, cancer vaccine and pembrolizumab can reduce the risk of recurrence or death by 44% in patients with stage III/IV melanoma after complete tumor resection (HR : 0.56, 95% CI: 0.31-1.08, one-sided p-value = 0.0266). The results of the KEYNOTE-942/mRNA-4157-P201 study are the first to demonstrate the efficacy of an investigational mRNA cancer therapy in a randomized clinical trial. The parties plan to discuss the results with regulatory agencies and initiate a phase III study in melanoma in 2023, and quickly Expanded to other tumor types.

Of course, any clinical research has different forms of interpretation, but positive clinical progress is always worth looking forward to. 2022 is a thing of the past. "There are tens of thousands of clinical trials, and only one or two of them can be seen in the end." What breakthroughs will be made in 2022 and what are the expectations for 2023? You may also wish to leave a message to discuss.