July 15, 2024

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mRNA Cancer Vaccine: 49% Reduction in Cancer Recurrence or Death

New Data on mRNA Cancer Vaccine: 49% Reduction in Cancer Recurrence or Death and 62% Reduction in Metastasis Risk!



New Data on mRNA Cancer Vaccine: 49% Reduction in Cancer Recurrence or Death and 62% Reduction in Metastasis Risk!

Recently, the collaborative efforts of the US companies Moderna and Merck yielded new research findings on their jointly developed personalized cancer vaccine mRNA-4157 (V940).

In a groundbreaking study, the mRNA-4157 (V940) vaccine, used in combination with the PD-1 inhibitor KEYTRUDA, demonstrated significant advantages in patients with stage III/IV (late-stage) melanoma at high risk of recurrence after complete tumor removal.

The combination therapy reduced the risk of cancer recurrence or death by 49% and lowered the risk of distant metastasis or death by 62%.

Key Information:

  1. The newly released research data surpasses previous reports presented in 2023 at the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), showcasing advancements in vaccine combination therapy that significantly improve the risks of cancer recurrence, death, or metastasis.

  2. The safety of the mRNA-4157 (V940) vaccine in combination with KEYTRUDA was confirmed.

  3. The two collaborating companies are actively conducting a pivotal phase 3 trial for melanoma patients and have initiated another phase 3 trial for non-small cell lung cancer patients. There are plans for rapid expansion to other types of tumors, and the outlook for treatment is eagerly anticipated.

Research Details:

Moderna and Merck jointly announced the latest developments in the research of the personalized cancer vaccine mRNA-4157 (V940). The vaccine, in combination with the PD-1 inhibitor KEYTRUDA, exhibited sustained advantages in patients with stage III/IV melanoma at high risk of recurrence after complete tumor removal, compared to using KEYTRUDA alone. The combination therapy significantly improved patients’ Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS).

Over approximately three years of planned follow-up, the combination therapy reduced the risk of cancer recurrence or death by 49% and the risk of distant metastasis or death by 62%.

RFS: The time during which patients show no signs or symptoms of cancer recurrence after treatment.

DMFS: The time during which patients, after treatment, do not exhibit distant metastasis from the primary tumor site.

The new research progress was based on follow-up data from the phase 2 randomized trial KEYNOTE-942/mRNA-4157-P201, which primarily evaluated the efficacy of mRNA-4157 (V940) vaccine in combination with KEYTRUDA in patients with stage III/IV melanoma at high risk of recurrence after complete tumor removal.

About KEYNOTE-942/mRNA-4157-P201 Trials:

KEYNOTE-942 is an ongoing randomized, open-label phase 2 clinical trial that recruited 157 patients with stage III/IV melanoma. After complete tumor surgical removal, patients were randomly assigned to two groups at a 2:1 ratio: one group received mRNA-4157 (V940) (once every three weeks for a total of 9 doses) in combination with KEYTRUDA (200 mg every three weeks for up to 18 cycles [approximately one year]), and the other group received KEYTRUDA monotherapy. The treatment lasted for approximately one year or until disease recurrence or unacceptable toxicity.

The primary endpoint of the study was RFS, and secondary endpoints included DMFS and safety.

Based on the data from the KEYNOTE-942/mRNA-4157-P201 study, the US Food and Drug Administration (FDA) and the European Medicines Agency granted breakthrough therapy designation and priority drug status for the combination therapy of mRNA-4157 (V940) vaccine and KEYTRUDA in the adjuvant treatment of melanoma patients at high risk of recurrence.

The companies had previously submitted the primary analysis data of the study, with plans for a two-year follow-up.

The primary endpoint data of RFS were reported in April 2023 at the AACR Annual Meeting, while the secondary endpoint data of DMFS were reported in June 2023 at the ASCO Annual Meeting. The primary analysis data had been submitted for publication in peer-reviewed journals.

The newly released data is an extension of the primary analysis data reported at the AACR and ASCO meetings in 2023, demonstrating that over approximately two years of planned follow-up, the combination of mRNA-4157 (V940) and KEYTRUDA reduced the risk of cancer recurrence or death by 44% and the risk of distant metastasis or death by 65%.

Regarding safety, adverse events observed during the trial were consistent with previous reports. Over approximately three years of planned follow-up, the proportion of patients in the mRNA-4157 (V940) and KEYTRUDA combination therapy group reporting grade ≥3 adverse events was approximately 25%, compared to around 20% in the KEYTRUDA monotherapy group, with little difference between the two groups.

Common adverse events with mRNA-4157 (V940) vaccine treatment included fatigue (60.6%), injection site pain (56.7%), and chills (49%).

In July 2023, Moderna and Merck announced the initiation of another crucial phase 3 clinical trial, INTerpath-001 (V940-001), primarily evaluating the mRNA-4157 (V940) vaccine in combination with KEYTRUDA as adjuvant treatment for stage IIB-IV melanoma patients at high risk of recurrence after complete tumor removal. Global recruitment for this trial has already begun.

Additionally, a global phase 3 clinical trial (INTerpath-002, NCT06077760) for non-small cell lung cancer patients has been initiated, with plans for rapid expansion to other tumor types.

About mRNA-4157 (V940) Vaccine:

mRNA-4157 (V940) is a novel personalized cancer vaccine based on messenger ribonucleic acid (mRNA), comprising a single synthetic mRNA molecule encoding up to 34 novel antigens.

The vaccine is designed based on the unique DNA sequence mutations of each patient’s tumor. When injected into the patient’s body, the vaccine stimulates the production of specific T cells for an anti-tumor response. When combined with the PD-1 inhibitor KEYTRUDA, it further enhances the patient’s immune system’s ability to detect and combat tumor cells.

New Data on mRNA Cancer Vaccine: 49% Reduction in Cancer Recurrence or Death and 62% Reduction in Metastasis Risk!

Design diagram of mRNA-4157 cancer vaccine(Source: Reference [2])

Write at the end:

Cancer vaccines hold immense clinical promise due to their ability to generate lasting immune memory in patients, providing enduring anti-cancer effects.

Cancer vaccines encompass preventive and therapeutic categories, with mRNA-4157 (V940) representing therapeutic cancer vaccines. These vaccines, including mRNA vaccines, cell vaccines, DNA vaccines, dendritic cell vaccines, nanovaccines, peptide vaccines, etc., have shown promising therapeutic results in various areas, such as malignant melanoma, lung cancer, glioblastoma, gastric cancer, and more. They offer a hopeful prospect in overcoming cancer.

Clinical trials for various therapeutic cancer vaccines are currently underway in renowned institutions in the US, the UK, and other countries, including Harvard Medical School-affiliated Dana-Farber Cancer Institute, Cleveland Clinic, and the Royal Marsden Hospital in the UK. These hospitals are official partnering institutions of Sheng Nuo, providing professional global medical resource matchmaking services, including scheduling one-on-one remote consultations with domestic and international experts and facilitating rapid processing of medical visas for treatment in authoritative overseas hospitals.

For more information on the latest developments and achievements in cancer vaccines, as well as other major and complex diseases’ cutting-edge research results, drugs, and treatment methods, please scan the QR code below to contact us. Sheng Nuo can provide professional global medical resource matchmaking services, including scheduling one-on-one remote consultations with domestic and international experts and facilitating rapid processing of medical visas for treatment in authoritative overseas hospitals.

New Data on mRNA Cancer Vaccine: 49% Reduction in Cancer Recurrence or Death and 62% Reduction in Metastasis Risk!


References:
[1] https://www.merck.com/news/moderna-and-merck-announce-mrna-4157-v940-in-combination-with-keytruda-pembrolizumab-demonstrated-continued-improvement-in-recurrence-free-survival-and-distant-metastasis-free-survival-in-pa/
[2] https://s29.q4cdn.com/435878511/files/doc_presentations/2022/09/Moderna-Final-R-D-Day-Slides_PDF-(09.08.22).pdf

(source:internet, reference only)

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