FDA approves skin cancer vaccine
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Important milestone in oncology: Vaccine against deadly stage of skin cancer successfully passes trial, — CNN A personalized mRNA cancer vaccine combined with immunotherapy Keytruda has successfully passed a late-stage trial for the treatment of melanoma. Interim results showed that the drug intismeran achieves its main goal - reducing the risk of recurrence - and also helps prevent the spread of cancer to other organs. The development is being carried out by Moderna and Merck. The study involved 1,137 patients with high-risk melanoma in stages 2b–4, whose tumors were surgically removed. Participants received up to nine doses of Keytruda along with the personalized vaccine or Keytruda alone for about a year. The vaccine is tailored to each patient based on their tumor mutations. Previous trial results showed that the combination therapy reduced the risk of relapse or death by 49% after five years. The new study found no new safety concerns; the most common side effects were fatigue, pain at the injection site and chills. Moderna and Merck plan to file for regulatory approval of the therapy in the coming months. The developers see the results as a potentially important step in the treatment of solid tumors. The mRNA technology allows for the creation of a vaccine tailored to the specific mutations of each patient's cancer. At the same time, the technology has faced criticism and cuts to government funding in the United States since the pandemic, although experts say serious concerns about its safety are unfounded. Amid the news, Moderna's shares rose by about 160%. The company is trying to reduce its reliance on the COVID-19 vaccine by expanding its portfolio to include drugs for influenza, norovirus, Lyme disease and cancer. Barclays estimates that the therapy could bring the manufacturer about $3 billion a year in melanoma treatment by 2035. Add News.LIVE as a trusted news source on Google
Important milestone in oncology: Vaccine against deadly stage of skin cancer successfully passes trial, — CNN A personalized mRNA cancer vaccine combined with immunotherapy Keytruda has successfully passed a late-stage trial for the treatment of melanoma. Interim results showed that the drug intismeran achieves its main goal - reducing the risk of recurrence - and also helps prevent the spread of cancer to other organs. The development is being carried out by Moderna and Merck. The study involved 1,137 patients with high-risk melanoma in stages 2b–4, whose tumors were surgically removed. Participants received up to nine doses of Keytruda along with the personalized vaccine or Keytruda alone for about a year. The vaccine is tailored to each patient based on their tumor mutations. Previous trial results showed that the combination therapy reduced the risk of relapse or death by 49% after five years. The new study found no new safety concerns; the most common side effects were fatigue, pain at the injection site and chills. Moderna and Merck plan to file for regulatory approval of the therapy in the coming months. The developers see the results as a potentially important step in the treatment of solid tumors. The mRNA technology allows for the creation of a vaccine tailored to the specific mutations of each patient's cancer. At the same time, the technology has faced criticism and cuts to government funding in the United States since the pandemic, although experts say serious concerns about its safety are unfounded. Amid the news, Moderna's shares rose by about 160%. The company is trying to reduce its reliance on the COVID-19 vaccine by expanding its portfolio to include drugs for influenza, norovirus, Lyme disease and cancer. Barclays estimates that the therapy could bring the manufacturer about $3 billion a year in melanoma treatment by 2035. Add News.LIVE as a trusted news source on Google
Results of a clinical trial show that the personalized MRND-based vaccine from Moderna and Merck, when combined with the drug Keytruda, reduced the risk of the deadliest type of skin cancer returning by 50 percent and the risk of its spread by nearly 60 percent. After the initial results were released, Moderna's stock price in financial markets increased by nearly 177 percent. Nilofar Mansouri, Iran International correspondent, reports
Moderna's cancer vaccine shows effectiveness against skin cancer in clinical trials; stock price temporarily rises 2.6 times Moderna and Merck are developing a messenger RNA vaccine. It has shown clinically significant improvement compared to monotherapy with the cancer immunotherapy drug Keytruda.
Will a 'dream vaccine' to prevent cancer recurrence be released? Moderna's stock surges 177% on successful skin cancer clinical trials.
Moderna and Merck said their personalized cancer vaccine reduced the risk of melanoma returning and spreading in a late-stage trial involving more than 1,000 patients, a finding that experts say could pave the way for treating other types of cancer. The mRNA-based vaccine is designed based on the characteristics of each patient's tumor and is given in combination with the immunotherapy drug Keytruda. The companies said adding the vaccine to the treatment did not cause any new side effects and the reactions observed were largely similar to those seen with flu or COVID-19 vaccines. Five-year data from a previous study showed that combining the vaccine with Keytruda reduced the risk of melanoma returning by 50 percent and the risk of its spreading by 59 percent. However, the researchers stressed that more long-term data is needed to assess the effect of this method on patients' lifespan. Moderna and Merck are currently continuing to test this technology for lung, bladder, kidney, stomach and pancreatic cancers.
**Pharmaceutical companies Moderna and Merck** said their personalized cancer vaccine reduced the risk of melanoma returning and spreading in a late-stage trial involving more than 1,000 patients, a breakthrough that experts say could pave the way for treating other types of cancer. The mRNA-based vaccine is designed based on the characteristics of each patient's tumor and is administered in conjunction with the immunotherapy drug Keytruda. The companies said adding the vaccine to the treatment did not cause any new side effects and the reactions observed were largely similar to those seen with flu or COVID-19 vaccines. Five-year data from a previous study showed that combining the vaccine with Keytruda reduced the risk of melanoma returning by 50 percent and the risk of its spreading by 59 percent. However, the researchers stressed that more long-term data is needed to assess the effect of this method on patients' lifespan. Moderna and Merck are currently continuing to test this technology for lung, bladder, kidney, stomach and pancreatic cancers.
What is this event about?
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by December 31, 2027, 11:59 PM ET. Otherwise, this market will resolve to "No".
Intismeran autogene refers to the individualized neoantigen therapy developed by Moderna and Merck and evaluated in the Phase 3 INTerpath-001 trial (NCT05933577), also known as mRNA-4157 and V940, together with any brand, trade, or nonproprietary name later assigned to that product, as well as any renamed or modified version that the relevant company or the FDA identify as the same product or a direct continuation of the V940/mRNA-4157 program.
Differences in neoantigen composition between patients will not affect resolution. Changes to the product's formulation will not affect resolution, provided the FDA approves the product described above. Approval as part of a combination regimen will qualify. Approval for a narrower population than the one studied in INTerpath-001 will qualify. Approval for an indication other than melanoma will also qualify. Both standard and accelerated approval will qualify.
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Act (PDUFA) dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source for this market will be official information from the FDA; however, a consensus of credible reporting may also be used.