The first half of this year has been riddled with market volatility and geopolitical tension. But 2025’s American Society of Clinical Oncology conference largely isn’t reflecting that turmoil.
In fact, despite the chill in the air, the Chicago-based five-day meeting has felt quite the opposite.
Though ASCO's CEO Clifford Hudis, M.D., kicked off the event with a warning about the devastating impact President Donald Trump's massive proposed budget cuts would have on the National Institutes of Health's National Cancer Institute, most attendees focused in on the potential that current pipeline programs could bring to Americans with cancer.
“In a fairly tumultuous world, where we just see concerns on funding and concerns on following the science, and then you come into a venue like this—it is energizing when you see the cutting-edge science and how smart some of these advancements are,” Teresa Bitetti, president of Takeda’s global oncology business unit, told Fierce Biotech at the conference.
“I think it is a little bit of a nice bubble to be in at the moment, given all that's going on in the world,” Bitetti added.
Specific to Takeda, Bitetti said the newly shared phase 3 data for the pharma’s Protagonist Therapeutics-partnered asset designed to treat a rare chronic blood disorder was also fueling her excitement.
The injectable hepcidin mimetic, called rusfertide, already met the hematology trial’s main endpoint, demonstrating a 76.9% clinical response when paired with standard of care compared to a 32.9% response for those receiving standard of care alone.
That finding, which was announced in March, is now supplemented by additional findings, including details on key secondary endpoints, all of which hit their target.
The late-stage trial enrolled patients with polycythemia vera (PV), a disease that increases the risk of life-threatening cardiovascular and thrombotic events, and therefore boosts the chances of requiring the regular removal of blood via phlebotomy in order to manage hematocrit levels.
However, only 27% of patients in the investigational treatment arm required phlebotomy over the duration of 32 weeks, compared to 78% of patients who received placebo plus the current standard of care.
“If I had had this years ago when I was practicing, I think I would have just been in tears with joy,” P.K. Morrow, M.D., head of Takeda’s oncology therapeutic area unit, told Fierce. The company is now on track to submit an approval request to the FDA in the second half of Takeda's fiscal year, which ends March 31, 2026.
“That's why I do love my job, it's not often in your career when you can bring forward a transformative medicine, and we're doing that,” Bitetti added. “That, to me, is super exciting and very fulfilling.”
The conference’s homebase, a sprawling convention center called McCormick Place, appears busy as ever. Fears that recent travel advisories cautioning international visitors from entering the U.S. would impact attendance seem not to have deterred global oncology leaders. A preliminary estimate from ASCO said international on-site registrations were on pace with last year, as of the second day of the conference.
For Merck & Co.’s Marjorie Green, M.D., the conference remains a place to push forward with innovative cancer treatments.
“Everyone is very happy with Keytruda, and we are too, but we know we can do better,” Merck’s senior vice president and head of oncology clinical development told Fierce.
She cited Merck’s investigational KRAS G12C inhibitor, known as MK-1084, which the company is studying in a recently launched phase 3 for metastatic non-small cell lung cancer (NSCLC), plus a pivotal late-stage study slated to start next month in advanced colorectal cancer.
In the NSCLC trial, the KRAS G12C inhibitor is being administered in combination with the company’s blockbuster PD-1 inhibitor Keytruda. The investigational duo will be compared against the standard of care in first-line metastatic nonsquamous NSCLC, which is Keytruda combined with pemetrexed and carboplatin.
“So, we’re trying to get rid of chemotherapy,” Green explained. “Rewriting textbooks, that’s what we’re going to do.”
And though, in the words of Fierce Pharma’s Angus Liu, this ASCO may not have “a lot of drama in the data” occurring, any chance to learn from other thought leaders and trials being presented is a golden one.
“Even if a study is a negative study, you've learned something important, and we build upon whatever that is,” Green said. “You've answered an important question and are advancing science. We always want to advance progress for patients.”
“The promise of ASCO is exciting,” she said.