New Delhi: Pharma giants Moderna and Merck reported Tuesday that the phase 2 trials of a new cancer treatment – jointly developed by their individual technologies — had demonstrated significant improvement in the recurrence free survival of patients with stage 3 and 4 skin cancer after surgery.
Moderna’s “investigational personalised mRNA cancer vaccine” in combination with Merck’s anti-PD-1 (Keytruda or a kind of immunotherapy) treatment had achieved this “statistically significant and clinically meaningful” result, the companies said in a joint statement.
The experimental vaccine, along with the immunotherapy, reduces the risk of recurrence or death by 44 percent compared to the immunotherapy alone, the release said.
The results follow Moderna’s previous success with its mRNA vaccine for COVID-19.
The personalised cancer vaccine — codenamed mRNA-4157/V940 — was created using mRNA genetic material from the respective tumors of 157 patients with stage 3 or stage 4 skin cancer or melanoma.
In the preliminary study, patients were randomly assigned to receive one of the two following treatments. One group received Keytruda, an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. The other group received Keytruda with the personalised cancer vaccine using mRNA technology.
Moderna’s experimental cancer vaccine, mRNA-4157/V940, is designed to boost patients’ immune system to generate a response to their specific tumors. Merck’s Keytruda, which is already used in the treatment of melanoma, stimulates the immune system to attack tumors. The second phase of the trial was initiated in 2019.
All patients had surgery to remove their melanoma, and for the vaccine group, Moderna scientists biopsied and genetically sequenced those tumors, then identified nearly three dozen genetic, personalised tumor flags, in the form of mRNA, for each patient’s immune system to recognise.
These were then combined and injected in patients’ arms — in the same way that the COVID-19 vaccine delivered instructions to the body target the virus’ spike protein genes. Except in this case, the immune system was trained to target and destroy melanoma cells rather than a virus, TIME Magazine explained.
After their surgeries, some patients received up to nine doses of the personalised cancer vaccine, given every three weeks, while also receiving Keytruda every three weeks for up to 18 cycles. Others received Keytruda alone.
Moderna and Merck said serious treatment-related adverse events occurred in 14.4 percent of patients who received the combination arm of mRNA-4157/V940 and Keytruda versus the 10 percent with Keytruda alone. Keytruda has some known risks for serious side effects, the companies said.
The companies released data from the study in a press release that has not yet been vetted by peers. They plan to publish full details in a peer-reviewed medical journal.
Melanoma, the most serious form of skin cancer, is characterised by the uncontrolled growth of pigment-producing cells. The rate of melanoma has been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.
Stéphane Bancel, Moderna’s chief executive officer, said, “We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualised cancer treatments to patients. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as with health authorities.”
She also said the results had emboldened Merck and Moderna to embark on a larger phase 3 trial that regulators tend to demand before approving a new treatment.
They plan to discuss the results with regulators and conduct a bigger study to confirm the combination’s safety and efficacy next year. Positive results of that study could clear the way for potential regulatory approval of Moderna’s experimental cancer vaccine, The Wall Street Journal reported.
The companies would also test the combination in other kinds of cancer. “We believe that this should work in many tumour types, not only melanoma,” Bancel said in an interview.
The clinical trial forms part of a 6-year collaboration between Merck and Moderna in the field of developing personalised cancer vaccines. In September, Merck paid $250 million to Moderna to exercise Merck’s option to jointly develop and commercialise the cancer vaccine, Peter Loftus reported in The Wall Street Journal.