HealthDay News — For patients with completely resected, high-risk cutaneous melanoma, the novel mRNA-based cancer vaccine (mRNA-4157) combined with pembrolizumab results in improved recurrence-free survival (RFS) compared with pembrolizumab alone, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 14 to 19 in Orlando, Florida.

Adnan Khattak, MBBS, from Hollywood Private Hospital in Nedlands, Australia, and colleagues randomly assigned eligible patients with completely resected, high-risk cutaneous melanoma to receive mRNA-4157 in combination with pembrolizumab or pembrolizumab alone (107 and 50 patients, respectively).

The researchers found that recurrence or death was reported in 22.4 and 40% of patients in the combination and monotherapy arms, respectively, at a median follow-up of 101 and 105 weeks. In the combination and monotherapy arms, the 18-month RFS rates were 78.6 and 62.2%, respectively. Protocol-defined statistical significance and clinically meaningful improvement in RFS was seen with the combination versus pembrolizumab, with a 44% reduction noted in the risk for recurrence or death. The number of patients reporting treatment-related grade 3 or higher adverse events was similar between the arms (25 and 18% for combination and monotherapy, respectively); fatigue was the most common mRNA-4157-related grade 3 event.

“Our phase 2b study shows that a neoantigen mRNA vaccine, when used in combination with pembrolizumab, resulted in prolonged time without recurrence or death compared with pembrolizumab alone,” a coauthor said in a statement.

Several authors disclosed financial ties to pharmaceutical companies, including Moderna and Merck, which are jointly developing and commercializing mRNA-4157/V940.

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HealthDay News — Adults with atopic dermatitis (AD) have an increased risk for developing melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC), with significantly higher risks seen for moderate-to-severe versus mild AD, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 17 to 21 in New Orleans.

Margaret Y. Huang, from the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues examined the risk for developing melanoma, SCC, and BCC among adults with AD in a retrospective cohort study using a claims database for 2007 to 2021. Data were included for 60 million adults aged 18 years or older with and without a diagnosis of AD who subsequently developed melanoma, SCC, or BCC.

The researchers found that adults with AD had significantly higher risks for developing melanoma, SCC, and BCC compared with those without AD (relative risks 1.23, 1.27, and 1.28, respectively) after adjustment for confounding variables. Adults with moderate-to-severe AD had a significantly higher risk for developing melanoma, SCC, and BCC compared with those with mild AD (relative risks, 1.11, 1.25, and 1.17, respectively).

“In conclusion, our findings support an increased risk of melanoma, SCC, and BCC development in adult patients with AD regardless of AD severity,” the authors write. “More mechanistic studies are necessary to understand AD and the development of skin cancers.”

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Yu Fujiwara, MD, from Mount Sinai Beth Israel in New York City, and colleagues conducted a systematic review and meta-analysis to examine how adding an immune checkpoint blockade to perioperative therapy affects treatment-related adverse events. Data were included from 28 randomized controlled trials with 16,976 cancer patients.

The researchers found no significant association for addition of an immune checkpoint blockade with increased treatment-related deaths, and this finding was consistent across immune checkpoint blockade subtypes. Across 9864 patients treated with an immune checkpoint blockade, 40 fatal toxicities were identified, with pneumonitis the most common (15.0%); among 7112 patients who were not treated with an immune checkpoint blockade, 13 fatal toxicities were identified. The incidence rates of grade 3 to 4 treatment-related adverse events, adverse events leading to treatment discontinuation, and treatment-related adverse events of any grade were increased with the addition of an immune checkpoint blockade (odds ratios, 2.73, 3.67, and 2.60, respectively). Increased incidence rates of treatment-related deaths and grade 3 to 4 adverse events were seen in association with an immune checkpoint blockade vs placebo design primarily used as adjuvant therapy (odds ratios, 4.02 and 5.31, respectively), while incidence was not increased with the addition of an immune checkpoint blockade in the neoadjuvant setting.

“Our analysis points to a need for further research into risk factors and identification of appropriate biomarkers to predict both efficacy and toxicity associated with cancer immunotherapy,” Fujiwara said in a statement.

Several authors disclosed ties to the biopharmaceutical industry.

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Artificial intelligence (AI) chatbots can sometimes provide accurate information about cancers, but these tools have limitations, according to a pair of studies published in JAMA Oncology.^1,2

In the first study, researchers assessed chatbots’ responses to the top Internet searches related to 5 cancers.¹ The chatbots provided information that was generally of high quality but not always actionable, and it was written at a college reading level.

In the second study, researchers found that a chatbot’s responses to queries about cancer treatments did not always align with recommendations in National Comprehensive Cancer Network (NCCN) guidelines.²

Most-Searched Queries About Cancers

Alexander Pan, of SUNY Downstate Health Sciences University in Brooklyn, New York, and colleagues evaluated chatbots’ responses to the top 5 search queries for skin, colorectal, prostate, lung, and breast cancers.¹ All queries contained the terms “cancer symptoms” and “what is [specific cancer].”

The researchers tested 4 chatbots, ChatGPT, Perplexity, Chatsonic, and Bing AI. The team used the DISCERN validation tool to assess the quality of information the chatbots provided and the Patient Education Materials Assessment Tool (PEMAT) to analyze the understandability and actionability of responses. On a scale of 1-5 (DISCERN) or 0%-100% (PEMAT), higher scores on the validation tools indicated higher-quality responses.

The quality of the cancer information provided by the chatbots was high, with a median DISCERN score of 5 (range, 2-5). However, the information was of moderate understandability. The median PEMAT score was 66.7% (range, 33.3%-90.1%), which the researchers deemed “college reading level.” Furthermore, the chatbots often failed to provide actionable responses, with a median PEMAT score of 20.0% (range, 0%-40.0%).

“These limitations suggest that AI chatbots should be used supplementarily and not as a primary source for medical information,” the researchers concluded.

ChatGPT and Cancer Treatment Recommendations

Shan Chen, of Mass General Brigham in Boston, and colleagues evaluated whether ChatGPT responded to queries about cancer treatments with recommendations that were in line with NCCN guidelines.²

Because ChatGPT’s knowledge cutoff was September 2021, the researchers measured responses against the 2021 NCCN guidelines. Responses were assessed by board-certified oncologists. The researchers used 104 queries for breast, prostate, and lung cancer. The chatbot provided at least 1 treatment recommendation for 102 of the queries (98%). All of these responses included at least 1 NCCN-concordant recommendation, but 35 (34.3%) also included at least 1 non-concordant recommendation. Additionally, 13 of 104 chatbot responses (12.5%) were “hallucinated”, that is, they were not part of any recommended treatment for the specified cancer.

“The chatbot did not purport to be a medical device and need not be held to such standards,” the researchers noted. “However, patients will likely use such technologies in their self-education, which may affect shared decision-making and the patient-clinician relationship. Developers should have some responsibility to distribute technologies that do not cause harm, and patients and clinicians need to be aware of these technologies’ limitations.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original references for a full list of disclosures.

HealthDay News — For patients with advanced melanoma, treatment with anti-programmed cell death 1 (anti-PD-1) results in improved response rate and longer progression-free survival for those with normal vitamin D levels, according to a study published online April 24 in Cancer.

Lukasz Galus, MD, from the Poznan University of Medical Sciences in Poland, and colleagues compared the effectiveness of anti-PD-1 therapy in patients with locally advanced, inoperable, or metastatic melanoma in relation to vitamin D levels. All patients received nivolumab or pembrolizumab as first-line therapy. The participants were divided into subgroups: 58 with reduced vitamin D levels, who did not receive supplementation or had ineffective supplementation, and 141 patients with normal vitamin D levels at baseline or obtained with supplementation.

The researchers found that the response rate was 36.2 vs 56.0% in the group with low vitamin D levels and not supplemented compared with the group with normal baseline levels or a normal level obtained with supplementation. In these groups, progression-free survival was 5.75 and 11.25 months, respectively. In terms of overall survival, there was a trend toward improved survival for the group with normal vitamin D levels (27 vs 31.5 months).

“The authors’ opinion is that assessment of vitamin D levels and appropriate vitamin D supplementation should be considered in every patient qualified for treatment with anti–PD‐1 immunotherapy,” the authors write.

Several authors disclosed financial ties to the biopharmaceutical industry.

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Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

The approval was based on a comprehensive data package that included a pharmacokinetic study (ClinicalTrials.gov Identifier: NCT05865574) in healthy individuals, as well as a phase 3 comparative study (ClinicalTrials.gov Identifier: NCT03329911) in patients with advanced nonsquamous non-small cell lung cancer.

“The global phase 3 clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity,” said professor Li Zhang, leading investigator for global phase 3 study of Avzivi. “The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.”

Biomarkers should be used when selecting cancer patients for immune checkpoint inhibitor (ICI) therapy, according to researchers. 

They found that cancer patients who have biomarker-positive tumors have better objective response rates (ORR), progression-free survival (PFS), and overall survival (OS) on ICI treatment.

These findings, from a meta-analysis, were published in the European Journal of Cancer.

The meta-analysis included 174 phase 1 and 2 trials that encompassed 19,178 cancer patients. The most common cancer types were melanoma (27 studies), non-small cell lung cancer (n=26), esophageal or gastric cancer (n=17), and breast cancer (n=14). 

Correlative predictive biomarkers were investigated in 132 studies. Biomarkers included PD-L1 expression (n=111), tumor mutational burden (n=20), mutations (n=17), tumor-infiltrating lymphocytes (n=15), microsatellite instability/mismatch repair deficiency (n=10), gene expression/RNA-based signatures (n=10), and other biomarkers.

Patients with biomarkers had a significantly higher ORR than patients without biomarkers; 30% and 16%, respectively (odds ratio [OR}, 2.15; 95% CI, 1.79-2.58, P <.0001).

Patients with biomarkers also had significantly better PFS (hazard ratio [HR], 0.55; 95% CI, 0.45-0.67; P <.0001) and OS (HR, 0.65; 95% CI, 0.53-0.80; P <.0001).

In a multivariate analysis, patients with biomarkers had significantly better ORRs (OR, 2.11; 95% CI, 1.77-2.51, P <.001) and PFS (HR, 0.56; 95% C.I, 0.43-0.72; P <.001). Due to a small number of studies, OS was not included in the multivariate analysis.

“This meta-analysis demonstrated that the use of immune-related biomarkers is important for selection of patients who will benefit from ICIs,” the researchers concluded. 

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Fountzilas E, Vo HH, Mueller P, et al. Correlation between biomarkers and treatment outcomes in diverse cancers: A systematic review and meta-analysis of phase I and II immunotherapy clinical trials. Eur J Cancer. Published online May 22, 2023. doi:10.1016/j.ejca.2023.05.015

Breakthroughs in targeted therapy and immunotherapy are partly responsible for the recent decline in cancer deaths seen in the United States, according to the AACR Cancer Progress Report 2023.¹

The overall rate of cancer death in the US fell by 33% between 1991 and 2020, which translates to 3.8 million lives saved, according to the report. Death rates have decreased for lung cancer, colorectal cancer, prostate cancer, female breast cancer, and melanoma.

“These gains have really reflected a whole variety of different advances, but mostly this has been about efforts in basic science,” AACR President Philip D. Greenberg, MD, of Fred Hutchinson Cancer Research Center in Seattle, said during a presentation about the AACR report.

Dr Greenberg noted that initiatives such as the Human Genome Project and The Cancer Genome Atlas have enabled the creation of targeted therapies, which are “increasingly precise and decreasingly toxic.”

Immunotherapy breakthroughs have also reduced the toxicity of treatments, leading to improved quality of life for patients. “Precision oncology, personalized medicine; it’s about creating drugs and using them to very selectively target the disease and not injure the person,” Dr Greenberg summarized.

The AACR report highlighted several targeted therapies with unique mechanisms of action that have been approved by the US Food and Drug Administration (FDA) since the early 2000s, including gefitinib in 2003, crizotinib in 2011, and sotorasib in 2021.

All of these therapies were approved to treat lung cancer, and these approvals coincided with declining lung cancer deaths. The decrease in lung cancer deaths per year grew from 0.9% between 1995 and 2005 to nearly 5% between 2014 and 2020.

The report also highlighted more recent FDA approvals. Between August 1, 2022, and July 31, 2023, the FDA approved 14 new cancer therapies and expanded the approved use of 12 therapies to encompass new cancers. The therapies include a range of cell-signaling inhibitors, antibody-drug conjugates, bispecific antibodies, and immune checkpoint inhibitors.

“A decade ago, there was 1 single immune checkpoint inhibitor,” Dr Greenberg pointed out. “Now . . . 11 checkpoint inhibitors have now been approved by the FDA up through 2023. And rather than using it to treat the single disease that it was approved for a decade ago, we now use it to treat 20 diseases.”

Two new imaging agents — pafolacianine and flotufolastat fluorine-18 —were also approved by the FDA between August 1, 2022, and July 31, 2023.

Ongoing Challenges

“Of course, despite all this progress, there’s a whole lot of work that needs to be done,” Dr Greenberg said. “There are still, even now, structural barriers for lots of people. There’s clearly disproportionate medical care being delivered to medically underserved populations. This includes, of course, racial and ethnic minorities, but it also includes the rural populations, which is not commonly appreciated, but rural populations participate very minimally in cancer trials.”

“Similarly, although precision medicine has really improved outcomes, we need ways of expanding that so that it includes more diseases,” Dr Greenberg added. “Pancreatic cancer, for example, and glioblastoma still have horrible 5-year relative survival rates, and so we need new advances.”

To address some of these challenges, the AACR has launched a new initiative known as the AACR Cancer Centers Alliance.²  The initiative aims to encourage collaboration among US cancer centers and “accelerate the pace of discovery by providing an ongoing mechanism for transferring new knowledge, sharing resources . . ., and driving innovation that impacts cancer science, cancer care delivery, and science and health policy.”²

Dr Greenberg suggested that the future of cancer research is bright. “I really enthusiastically look forward to what can happen,” he said. “I think there’s no reason not to be optimistic. . . . We’re in this time of unparalleled opportunities.”

Disclosures: Dr Greenberg has relationships with Affini-T, Rapt Therapeutics, Elpiscience, Fibrogen, Immunoscape, Metagenomi, Earli, Catalio, and Nextech. No disclosures were provided in relation to the AACR Cancer Progress Report 2023. Some authors of the Cancer Discovery article declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the article for a full list of disclosures.

Cancer patients were more likely to die from the BA.1 and BA.2 omicron variants of SARS-CoV-2 than from wild-type SARS-CoV-2, according to research published in JAMA Oncology.^1,2

The study showed that, among US cancer patients, COVID-19 deaths were more likely during the initial omicron wave when the BA.1 and BA.2 variants were in circulation (December 2021 to February 2022) than when wild-type SARS-CoV-2 was circulating (December 2020 to February 2021).

According to data from the US Centers for Disease Control and Prevention, there were 54,692 COVID-19 deaths among patients with cancer and 1,008,510 COVID-19 deaths in the general population from March 1, 2020, through May 31, 2022.

This study included 34,350 patients with cancer and 628,156 individuals from the general population who died from COVID-19 when wild-type SARS-CoV-2 was in circulation (December 2020-February 2021), the delta variant was in circulation (July 2021-November 2021), or the BA.1 and BA.2 omicron variants were in circulation (December 2021-February 2022).

The highest number of COVID-19-related deaths among patients with cancer occurred during the 2021-2022 omicron wave. At the peak of this wave, in January 2022, there were 18% more deaths than during the peak of the wild-type period, which occurred during January 2021.

This trend was maintained when patients were stratified by age group. The number of deaths per month among patients with cancer younger than 50 years of age was 64% higher during the 2021 to 2022 omicron wave than during the wild-type wave. The number was 62% higher among patients aged 50 to 59 years, 31% higher for those aged 60 to 69 years, and 16% higher for those aged 70 to 79 years.

When the researchers looked at individual cancer types, they found that COVID-19 deaths were more likely during the 2021-2022 omicron wave for most cancer types. The exceptions were brain cancer (mortality ratio [MR], 0.77; 95% CI, 0.65-0.90), thyroid cancer (MR, 0.76; 95% CI, 0.54-0.99), and bladder cancer (MR, 0.58; 95% CI, 0.52-0.65).

Patients with lymphoma had the greatest increase in deaths from the wild-type wave to the 2021 to 2022 omicron wave, at 38% (mortality ratio [MR], 1.38; 95% CI, 1.31-1.45).

In the general population, the highest number of COVID-19 deaths per month occurred when wild-type SARS-CoV-2 was prevalent. At the peak of the initial omicron wave in January 2022, there were 21% fewer deaths in the general US population than at the peak of the wild-type period in January 2021 (MR, 0.69; 95% CI, 0.69-0.70).

“[W]hile the general US population experienced a large reduction in COVID-19 mortality during the winter Omicron period, patients with cancer experienced the highest COVID-19 mortality during the winter Omicron period, likely due to increased SARS-CoV-2 exposure during this period combined with the reduced effectiveness of COVID-19 vaccines and increased risk of COVID-19 mortality in this population,” the researchers wrote. “With future COVID-19 waves imminent, strategies to protect those at highest risk should remain a high priority, even during future pandemic waves with less virulent SARS-CoV-2 variants.”

Disclosures: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Potter AL, Vaddaraju V, Venkateswaran S, et al. Deaths due to COVID-19 in patients with cancer during different waves of the pandemic in the US. JAMA Oncol. Published online August 31, 2023. doi: 10.1001/jamaoncol.2023.3066

2. SARS-CoV-2 sequences by variant, United States, Jan 3, 2022. Our World in Data. Updated August 22, 2023. Accessed September 1, 2023.

Adding mRNA-4157, a personalized cancer vaccine, to treatment with pembrolizumab improves recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with high-risk, resected melanoma, a phase 2 trial suggests.

At a median follow-up of about 2 years, mRNA-4157 and pembrolizumab yielded a 44% reduction in the risk of recurrence or death and a 65% reduction in distant metastasis or death over pembrolizumab alone, said Adnan Khattak, PhD, of Hollywood Private Hospital and Edith Cowan University in Perth, Australia.

Dr Khattak reported these results, from the KEYNOTE-942 trial, at the ASCO Annual Meeting 2023.

The trial (ClinicalTrials.gov Identifier: NCT03897881) included 157 patients with resected, stage IIIB-IV cutaneous melanoma at a high risk of recurrence. The patients were randomly assigned to receive pembrolizumab monotherapy (n=50) or the combination of mRNA-4157 and pembrolizumab (n=107). 

The patients had undergone complete resection no more than 13 weeks prior to their first pembrolizumab dose and were free of disease at study entry. Baseline characteristics were well balanced between the treatment arms. 

In both arms, pembrolizumab treatment continued for up to 1 year (200 mg every 3 weeks for up to 18 cycles). In the combination arm, patients also received mRNA-4157 as a 1 mg intramuscular injection every 3 weeks for up to 9 doses. 

The median follow-up was 23 months for the combination arm and 24 months for monotherapy arm. Patients in the mRNA-4157 arm had a significantly lower risk of relapse or death than patients in the pembrolizumab monotherapy arm (hazard ratio [HR], 0.561; 95% CI, 0.309-1.017; P =.0266). 

The 1-year RFS rate was 83.4% in the mRNA-4157 arm and 77.1% in the monotherapy arm. The 18-month RFS rates were 78.6% and 62.2%, respectively. Patients in the mRNA-4157 arm also had a significantly lower risk of distant metastasis or death than patients in the monotherapy arm (HR, 0.347; 95% CI, 0.145-0.828; P =.0063). The 18-month DMFS rates were 91.8% and 76.8%, respectively.

The mRNA-4157 vaccine was not associated with an increase in immune-mediated toxicity, Dr Khattak noted. All patients in the mRNA-4157 arm experienced treatment-related adverse events (TRAEs), compared to 82% of patients in the pembrolizumab monotherapy arm. Grade 3 or higher TRAEs were seen in 25% and 18% of patients, respectively. 

The most common TRAEs related to mRNA-4157 or the combination were fatigue (60.6%), injection site pain (55.8%), and chills (50.0%).

This study is the first randomized trial showing improved RFS and DMFS for an individualized neoantigen treatment approach, Dr Khattak said. He noted that the US Food and Drug Administration granted mRNA-4157 plus pembrolizumab breakthrough therapy designation in February of this year.

Disclosures: This research was supported by Moderna. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Khattak A, Weber JS, Meniawy T, et al. Distant metastasis-free survival results from the randomized, phase 2 mRNA-4157-P201/KEYNOTE-942 trial. ASCO 2023. June 2-6, 2023. Abstract LBA9503.

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

The cisplatin shortage that has affected cancer centers and patients across the US is nearly resolved, according to a statement from the Biden Administration.¹

The White House reported last week that the cisplatin supply has been restored to almost 100% of pre-shortage levels.

According to the US Food and Drug Administration’s (FDA) drug shortage database, 3 companies had cisplatin available on allocation as of September 18.² Additional supplies of cisplatin are expected to be released this month and next month.

The shortage of cisplatin has occurred alongside prolonged shortages of several other cancer drugs, including methotrexate and carboplatin.³ In June, the National Comprehensive Cancer Network (NCCN) published survey results reporting that cisplatin was in short supply at 70% of included cancer centers, and carboplatin was in short supply at 93%.⁴

The FDA has worked to alleviate these shortages over the past several months.¹ In June, the FDA announced that it would work with Chinese drugmaker Qilu Pharmaceutical and Canadian pharmaceutical company Apotex to temporarily import cisplatin.⁵ According to the FDA, distribution of this product has been completed.²

The FDA also worked with various drug manufacturers to increase production of cisplatin, carboplatin, and methotrexate.¹ According to the FDA database, several companies have methotrexate and carboplatin available now, and additional supplies of both drugs are expected this month and next month.²

“The Administration will continue to work through the FDA, the Department of Health and Human Services, and other agencies to address and prevent drug shortages and mitigate impacts to people facing a cancer diagnosis,” the White House said in its statement.¹

Drug-Induced Photosensitivity

People with advanced melanomas who received the vaccine plus Merck’s cancer drug Keytruda were 49% less likely to die or have their cancer return after 3 years than those who were given only Keytruda, vaccine maker Moderna Inc. announced Friday.

“Importantly for this technology, the […] study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over Keytruda alone in adjuvant melanoma,” Moderna Senior Vice President Kyle Holen, MD, said in a company news release. “We look forward to sharing these data with people impacted by this disease and the broader scientific community.”

The findings are based on an ongoing randomized trial involving 157 patients with high-risk stage 3/4 melanoma who first had surgery to completely remove cancerous growths. Patients received 1mg of the mRNA vaccine every 3 weeks for a total of 9 doses, along with 200mg of Keytruda every 3 weeks for about a year. Their outcomes were compared to those using Keytruda alone for approximately a year.

The companies have already begun phase 3 trials of the vaccine-drug combo, and the  Food and Drug Administration has designated the treatment as a breakthrough therapy to speed its development and review.

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