First mRNA pancreatic cancer vaccine patient disease-free

Seven years after she became the world's first person to receive a personalized mRNA vaccine for pancreatic cancer, Donna Gustafson shows no evidence of the disease that was expected to kill her, NPR reported on Nov. 2. Her story comes as mRNA cancer vaccines draw growing attention. A large melanoma trial recently succeeded, and federal health officials are getting ready to launch a national effort to speed development.npr.org

A rare survivor

According to NPR, Gustafson is a 72-year-old retired accountant. Her vaccine was designed from samples of her own tumor to train her immune cells to recognize mutant proteins on cancer cells. She was one of 16 patients in a small trial at Memorial Sloan Kettering Cancer Center and received nine doses along with surgery and chemotherapy. The vaccine worked in eight of the patients, and seven of them are still alive. "I have had 100% quality of life," Gustafson told NPR. Vinod Balachandran, the surgeon-scientist who led the trial, said her immune response showed a "ten thousand fold expansion" of cancer-fighting cells that stayed high for years.npr.org

The vaccine, autogene cevumeran, is being developed by BioNTech ↗ 1.92% and Genentech Roche Holding AG ↗ 1.70%. A 260-patient trial began in 2023, Investor's Business Daily reported via Yahoo Finance.finance.yahoo.com

Melanoma results raise expectations

Merck ↘ 0.14% and Moderna ↗ 5.27% said their personalized vaccine intismeran autogene, given with Keytruda, lowered the risk of recurrence or death by 42% compared with Keytruda alone. The Phase 3 INTerpath-001 trial enrolled 1,137 patients with resected stage IIB-IV melanoma, according to Merck. After two years, 82.2% of patients on the combination had no recurrence, compared with 70.0% on Keytruda alone. Overall survival data are not yet mature. The results were presented Oct. 24 at the ESMO Congress in Madrid, after a leak forced the companies to release the findings early. Analysts at RBC Capital Markets warned that "commercial success is far less certain" even if regulators approve the vaccine, Ground News summarized.merck.com+3

A federal push

The National Cancer Institute and the Foundation for the NIH are planning a $200 million public-private partnership, the Therapeutic Cancer Vaccines Initiative, to build trial networks and infrastructure, STAT reported. NCI meeting minutes show the first trials would target pancreatic, liver, colorectal and pediatric cancers. The program is expected to start in December. The effort is moving forward even though HHS cut $500 million in mRNA vaccine projects, Reuters reported. NPR said Sloan Kettering plans to expand on-site manufacturing of personalized vaccines next year.reuters.com+2

Researchers still don't know why some mRNA vaccine trials fail while others succeed, NPR noted. Gustafson's husband, Ed, described what the past seven years have meant to the couple: "We just live every day for the day now."npr.org