Industry news, page-1814

from the website
https://www.biopharmadive.com/news/biotech-10-clinical-trials-watch-2024-second-half/720005/

COMPANY:

Summit Therapeutics

DISEASE:

Lung cancer

TREATMENT TYPE:

Bispecific antibody

TRIAL:

HARMONi-2

WHY IT’S IMPORTANT:

Merck & Co.’s cancer immunotherapy Keytruda is one of the pharmaceutical industry’s most lucrative products. The drug has earned 40 approvals since its first in 2014 and became the world’s best-selling medicine last year, with $25 billion in global sales. So it came as a shock when a small biotechnology company, Summit Therapeutics, claimed in May that a drug it’s been developing “decisively” beat Keytruda in a head-to-head trial.

The drug, ivonescimab, was discovered by China-based biotech Akeso and partially licensed to Summit in 2022. Unlike Keytruda, which blocks the immune-suppressing protein PD-1, ivonescimab inhibits PD-1 as well as another target, VEGF, that’s implicated in tumor growth. Summit and Akeso are testing it in a trio of Phase 3 studies in non-small cell lung cancer, two of which pit the drug against Keytruda.

HARMONi-2 is the first of those studies to read out results. According to the company, an interim analysis showed treatment with ivonescimab led to a “statistically significant and clinically meaningful” slowing of tumor progression compared to Keytruda alone.

But the study was run only in China, making it “unlikely” to be enough to support global approvals, Leerink Partners analyst Daina Graybosch wrote in May. It didn’t test ivonescimab against the Keytruda-chemotherapy combination that’s now standard in non-small cell lung cancer. And Summit didn’t disclose specifics either, leaving unclear key details about the drug’s performance.

Summit has said those specifics will be disclosed at a medical meeting later this year. While the findings won’t prove whether ivonescimab is a threat to Keytruda, they will show the “relative contribution” of each of the study’s subgroups, which is important in assessing the drug’s efficacy and competitive standing, Graybosch wrote.

They could also help investors better gauge ivonescimab’s chances of succeeding in a study called HARMONi-3, a multi-country trial testing Summit’s drug and chemotherapy against Keytruda and chemo. Results from that trial are expected in 2027, according to a federal database. — Ben Fidler