Today, BioPharma Dive is highlighting some notable clinical trial updates presented at the annual European Society for Medical Oncology meeting. Over the last few days, several large pharmaceutical and biotechnology companies released detailed study data on new and emerging medicines for an array of different tumors.
Below are three notable storylines and a look at how they’re being interpreted by investors and analysts.
A cancer vaccine debate
The Phase 3 success of Moderna and Merck & Co.’s vaccine intismeran autogene in melanoma was a “genuine scientific milestone” in melanoma treatment, wrote RBC Capital Markets analyst Trung Huynh. The 42% reduction in the relative risk of recurrence or death associated with treatment in that study, which was presented in detail at ESMO over the weekend, is a “clinically meaningful and likely approvable result,” he added in a note on Saturday.
Wall Street investors have had a different interpretation. Since the results were released prematurely on Thursday afternoon, Moderna’s share price — which had skyrocketed over the last few months — has plunged by double digits. Multiple industry analysts have defended Moderna since then, calling the reaction a “sell-the-news” response to data that had met expectations. Yet that optimism was countered by worries that Moderna’s current valuation is only justified if intismeran works in other tumor types. Investors are also skeptical about the manufacturing and commercial potential of a patient-specific therapy like intismeran.
Melanoma is known to be particularly susceptible to immune-boosting treatments because of the number of mutations these tumors express. Those characteristics made melanoma the ideal setting for a first-of-its-kind therapy such as intismeran. But the results don’t guarantee success elsewhere, and investigators interviewed by BioPharma Dive declined to make any predictions ahead of key readouts in lung, kidney or bladder tumors.
As an “individualized neoantigen therapy,” intismeran is produced through a complicated process that involves sequencing patient tumors and using that information to create a specialized vaccine. In the Phase 3 trial, for instance, patients waited a median of 64 days before receiving their first dose. The treatment turnaround was less critical in the post-surgical “adjuvant” setting, where intismeran’s objective was to keep disease from returning. But Moderna and Merck also hope the therapy can be an option in cancers that are actively spreading.
One study investigator is hopeful. For intismeran to be a practical solution, Moderna and Merck will need to help oncologists prepare for use early on, said Janice Mehnert, director of melanoma and cutaneous medical oncology at NYU Langone Health.
“I do think that’s something that’s manageable,” Mehnert said. “As technology gets better and workflows change, we’ll get better.” — Jonathan Gardner
Roche’s KRAS progress
Roche is a relative latecomer in the push to develop medicines for cancers driven by tough-to-drug “KRAS” mutations. But it has a chance to leapfrog some competitors thanks to the progress of a drug called divarasib.
In July, Roche disclosed that divarasib topped two marketed medicines — Bristol Myers Squibb’s Krazati and Amgen’s Lumakras — in a Phase 3 trial. That study tested all three drugs in patients whose non-small cell lung tumors have a particular KRAS mutation known as “G12C.” Roche didn’t provide specifics at the time, but said that in people with these alterations, divarasib was associated with statistical improvements on measures of survival as well as tumor progression.
Detailed data at ESMO suggest divarasib has now “set a new bar” in this setting, wrote Stifel analyst Laura Prendergast. Divarasib cut the risk of death or disease progression by 42% and lowered the likelihood of death, specifically, by 44%. A primary analysis found that participants on Roche’s medicine lived a median of roughly 18 months, versus a year for people on Krazati or Lumakras.
Importantly, the results “confirm” a survival benefit for divarasib that first-generation drugs weren’t able to achieve, wrote RBC analyst Huynh. And even though patients on divarasib were treated nearly twice as long, it was still associated with lower rates of severe adverse events or treatment-related side effects that were deemed “Grade 3” or worse.
During an ESMO presentation, one researcher described the findings as an “immense innovation.” But he also cautioned that both Krazati and Lumakras have run into trouble with insurers and that divarasib might struggle, too, as it wasn’t tested against the standard chemotherapy docetaxel, Huynh wrote.
Roche is optimistic. On an earnings call last week, executives cited the study data in upgrading their peak sales expectations for divarasib from 2 billion Swiss francs to 3 billion, equivalent to about $3.6 billion annually. Krazati and Lumakras respectively banked $205 million and $363 million last year. — Ben Fidler
Amgen’s ‘unprecedented’ lung cancer data
“Small cell” lung cancer accounts for around 10% to 15% of lung tumors and is known as the tougher of the two major forms of the disease to treat. Typically linked to smoking, these tumors grow and spread more quickly than “non-small cell” lung cancers. Many people already have “extensive stage” disease by the time they’re diagnosed, too, meaning their cancers have already spread to both lungs or other organs.
Since its approval in 2024, Amgen’s Imdelltra has established itself as a go-to treatment for patients whose disease has progressed following chemotherapy. That use has made Imdelltra one of the big biotech’s fastest-growing products. Sales reached $627 million in 2025 and are on track to surpass $1 billion this year.
Data presented at ESMO and simultaneously published in the New England Journal of Medicine could drive those figures substantially higher. In September, Amgen revealed, without details, that a combination of Imdelltra and the cancer immunotherapy Imfinzi topped Imfinzi alone when given as a “maintenance” therapy following initial treatment. Over the weekend, Amgen revealed that combination reduced the risk of death by 58% versus Imfinzi alone. Those on the former regimen lived a median of 21.1 months, compared to 12.7 months for Imfinzi recipients.
Those findings were met with a “standing ovation” at ESMO and described by an independent researcher as “fundamentally chang[ing] the outcome” of ES-SCLC treatment, wrote TD Cowen analyst Yaron Werber. Importantly, the drug combination’s safety was “manageable” and “comparable” to what’s seen with Imfinzi alone, he added.
For Amgen, the study “validates earlier-line use” of Imdelltra, which the company is focused on moving into initial treatment, wrote Mizuho Securities analyst Salim Syed. Consensus estimates already have the drug peaking at $4 billion in annual sales. But approvals in additional treatment lines could open up a $9.6 billion market opportunity, Werber wrote.
The “unprecedented” survival benefit “sets a clear new standard of care,” wrote William Blair analyst Matt Phipps, in a separate note. — Ben Fidler