Merck & Co. and Moderna always knew they would make headlines in Madrid this week, but not in the way it played out.
The partners’ detailed data for a phase 3 win for their autogenic intismeran cancer vaccine is expected to be the highlight of the European Society for Medical Oncology (ESMO) Congress, which will headline Saturday’s coveted Presidential Symposium.
But an unexpected leak of ESMO data forced the partners to rework their plans and make their findings public two days early. Amid this drama, both companies’ stock prices took a hit as investors scrambled to digest the data.
This data showed that at 24 months, patients receiving intismeran and Merck’s blockbuster oncology treatment Keytruda experienced a relapse-free survival (RFS) rate of 82.2%, compared to 70% for patients receiving Keytruda alone in some melanoma patients. The hazard ratio was 0.58, indicating that adding the experimental cancer vaccine to Keytruda reduced the risk of recurrence or death by 42% in the deadliest form of skin cancer.
Although the RFS result was as expected, the distant metastasis-free survival (DMFS) data did not meet expectations set by the Phase 2 readout. At 24 months, the DMFS rate in the cancer vaccinated cohort was 88.5%, compared to 80.2% in the Keytruda control arm. The hazard ratio was 0.62, indicating a 38% reduction in the risk of distant metastases or death.
In an interview on the sidelines of ESMO on Saturday morning, Shweta Jain, vice president of global clinical development and oncology clinical research at Merck, acknowledged that the Phase 2 results had raised expectations for the Phase 3 readout.
“People should have expectations; I don’t think we can change that,” Jain told Fierce.
“I think it’s hype or not, the question is: what have you done for the patients?” she continued. “For us, when you look at the whole package, it looks like the benefit is real. It looks like we’re getting closer to that curative potential. So we’re confident and remain happy with the data.”
Jain highlighted the potential of the intismeran-Keytruda combo to reduce the risk of distant metastases or death by 38% compared to Keytruda alone as “pretty significant.” Distant metastases occur when cancer cells break away from the primary tumor and form new tumors in other organs.
“With this type of powerful regimen, if you can reduce not only local but also distant recurrences, that counts,” she explained. “You can continue to argue about the numbers. At the end of the day, this is still an important trial.”
While Jain and his team are clearly very proud of the data, was it a blow to lose control of how the data was released into the world?
“Look, it’s unfortunate, isn’t it? she said to Fierce. “We all travel that far to make sure we have a scientifically engaged exchange of information.”
“But at the end of the day, ‘that’s what it is,’ that’s what you can tell yourself,” she added. “It’s happened. The data is still compelling. You know, we’re able to show that the Phase 3 numbers are reasonable. So that’s how I see it.”
So there wasn’t a frantic rewrite of Saturday’s presentation in the Merck and Moderna offices to reframe the data in a new way?
“No rewriting,” Jain said. “Nothing has changed on our end. We have the same presentation. We have the same things that we were going to do. Of course, you want to do it together. You want to do it on the day. But it happens.”
For Merck, the Phase 3 data validates a collaboration with Moderna that dates back to 2016, when the two companies began working together to develop a series of mRNA vaccines.
“I think in terms of collaboration, this is probably the pinnacle of how two groups of scientists can come together and think outside the box,” Jain explained.
“There was a lot of institutional knowledge about pembrolizumab. There was a lot of understanding of how the immune system works and the types of patients who seem to benefit from it,” she continued. “Then Moderna has a lot of institutional knowledge on how to understand the mRNA platform and the neoantigen.”
Merck is now preparing to get the hoped-for FDA approval for intismeran next year.
“We’re working as fast as we can to make sure we can get things ready and sent to the agency,” Jain told Fierce.
Meanwhile, the pharmaceutical company has launched phase 2 studies for the vaccine against a range of other cancers, including renal cell carcinoma, bladder cancer and non-small cell lung cancer.
It’s no secret that Merck has long been looking for worthy successors to King Keytruda. According to Jain, intismeran is part of a “diversified strategy” that leverages the pharmaceutical industry’s “deeper understanding of various types of malignancies.”
This portfolio is fully on display at ESMO, where Merck will also share Phase 3 data from its TROP2-directed antibody-drug conjugate bag-TMT in trials for endometrial cancer and non-small cell lung cancer, as well as Keytruda as a first-line treatment for one type of endometrial cancer.
“I wouldn’t say we’re going after Keytruda, so to speak, but I would say we’re definitely evolving,” Jain told Fierce. “We make sure we understand this historical knowledge, understand the lessons we need to learn, and then continue to develop better therapies for patients. »
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