"Science and Innovation Board Daily" December 14th (Editor Zheng Yuanfang) On Tuesday local time, Moderna released data showing that in the clinical phase 2b trial, through its combination therapy of "individualized cancer vaccine mRNA-4157/V940 and PD-1 inhibitor Keytruda" jointly developed with Merck , compared with Keytruda monotherapy, after the tumors in patients with stage III and IV melanoma are completely removed, can statistically significantly and clinically meaningfully improve the recurrence-free survival (RFS) of the main endpoints of the trial. This combination therapy can reduce the risk of recurrence or death by 44% .
In this phase of the trial, a total of 157 patients participated. All of these patients have undergone melanoma-related surgery but are still considered high-risk patients, and the trial has maintained a year-long follow-up. Among them, one group of patients received nine doses of mRNA-4157/V940 vaccine and took Keytruda drugs; the other group of patients only used Keytruda.
Based on this result, the two companies will discuss the trial results with regulatory authorities, and plan to launch a Phase 3 clinical trial in melanoma patients next year, and expand the application of this combination therapy to other tumor types.
In skin cancer , melanoma has always been an extremely deadly type. In the past few decades, the incidence of melanoma has continued to rise, and the number of newly confirmed melanoma patients worldwide reached 325,000 in 2020. It is estimated that the 5-year survival rates of patients with stage III and IV melanoma are 60.3% and 16.2% respectively.
Nowadays, the experimental data of Moderna and Merck may be expected to bring certain hope of curing melanoma.
, CEO of Moderna, said that for the treatment of the new coronavirus, the mRNA vaccine is transformative, and this phase 2b clinical trial is also the first time that the mRNA vaccine has shown the efficacy of treating melanoma in a randomized clinical trial.
In addition to the treatment of Moderna and Merck, BioNTech has also applied mRNA vaccine to melanoma treatment:
Its BNT122 cancer vaccine jointly developed with Roche targets metastatic melanoma and can target 20 tumor neoantigens, and has shown anti-tumor activity in patients with stage I solid tumor . At present, BNT122 has entered the second phase of clinical stage, and is also used in combination with Keytruda to treat in patients with advanced melanoma.
BNT111 cancer vaccine is a leading candidate for FixVac platform that BioNTech has fully owned, and is also used to treat advanced melanoma. The vaccine is currently in Phase II clinical trials to treat patients with refractory/recurrent, unresectable stage III or stage IV melanoma in anti-PD-1 therapy.
Overall, mRNA vaccines can be divided into universal tumor vaccines and personalized tumor vaccines.
, and the mRNA-4157/V940 mentioned in this article belongs to the latter. The cancer vaccine contains a single synthetic mRNA molecule encoding up to 34 neoantigens designed by algorithms based on the mutation characteristics of the DNA sequence of each patient's tumor.
Just like the category name, this vaccine also emphasizes the "personalization" of patients, so the vaccines for different patients are actually not exactly the same. It takes about 45 days from obtaining tumor samples to treating patients. The two companies are still trying to shorten this time.
In the field of tumor vaccines, mRNA technology has the advantages of multi-antigen combination and fast R&D speed. CITIC Securities pointed out that personalized tumor vaccine can more effectively exert the multi-antigen combined advantages of mRNA .
However, although the results of this experiment by Moderna and Merck are statistically significant, they have not been reviewed by independent scientists. Silicon Valley Bank analyst Daina Graybosch believes that the second phase trial data is indeed amazing, but the detailed data still needs to be carefully examined to truly convince experts and investors that the third phase trial can be successful.
The British " Financial Times " also pointed out that for biopharmaceuticals, phase 3 clinical trials are a hurdle - most new drugs/therapies will fail in phase 3 even if they succeed in phase 2 trials.
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