From the 17th to the 21st (local time) in Berlin, Germany, global big pharmaceutical companies unveiled results from research and development on new cancer drugs at the European Society for Medical Oncology (ESMO) annual congress. ESMO is considered one of the world's three major cancer conferences along with the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR). Oncology is the largest segment by market size in pharmaceuticals, making the event a focus for the industry.
◇ ADCs may break through limits in treating "triple-negative breast cancer"
At this congress, clinical trial results for Antibody-Drug Conjugate (ADC) cancer therapies under development by global big pharma, including the United Kingdom's AstraZeneca, the United States' Merck (MSD) and Gilead, and Switzerland's Novartis, drew major attention.
In particular, a series of clinical results were announced for ADC drug candidates targeting triple-negative breast cancer (TNBC), a disease with limits to treatment using existing immuno-oncology drugs. ADCs attach a drug to an antibody and deliver it precisely to cancer cells, which means less damage to normal cells and better efficacy, earning the nickname "guided missile that targets cancer cells."
Notably, Datroway (ingredient name datopotamab deruxtecan), an ADC cancer drug co-developed and commercialized by AstraZeneca and Daiichi Sankyo, drew attention with phase 3 results demonstrating treatment benefit in TNBC patients at this congress.
According to the presentation, in this study Datroway reduced the risk of death by 21% compared with chemotherapy. Progression-free survival, the period during which the disease does not worsen after treatment, was 10.8 months in the Datroway group, roughly double the 5.6 months in the control group.
There is also an assessment that the green light has come on for expanding the indication (scope of treatment), a key task for a new drug's commercial success. Even within breast cancer and lung cancer, the genetic mutations that drive disease differ. As a result, therapies that benefit patients also differ by cause of onset and target mutations.
Datroway first won U.S. Food and Drug Administration (FDA) approval based on clinical results in adult breast cancer patients with unresectable or metastatic, hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative disease. It then received accelerated approval in Jun. as a treatment for lung cancer with epidermal growth factor receptor (EGFR) mutations.
Gilead Sciences presented clinical results for its ADC cancer drug Trodelvy in TNBC patients who are PD-L1 negative. PD-L1 is a protein present on the surface of cancer cells. Trodelvy previously received FDA approval in 2020 as a second-line or later treatment for metastatic triple-negative breast cancer. In Korea, the Ministry of Food and Drug Safety approved it in 2023.
According to the announcement, Trodelvy reduced the risk of disease progression or death by 38% compared with chemotherapy. Gilead said that, given the positive results in trials for PD-L1–positive patients, Trodelvy will establish itself as the "backbone" therapy in first-line TNBC treatment.
◇ "Radiation missile" emerges as new standard for prostate cancer treatment
Novartis drew attention with phase 3 results confirming the combination benefit of Pluvicto (177Lu-PSMA-617), a radioligand therapy (RLT) launched in 2022, in treating prostate cancer.
Pluvicto works by binding lutetium-177, a radioactive isotope, to an antigen highly expressed in prostate cancer and delivering therapeutic radiation directly. It selectively destroys cancer cells with radiation. Previously, chemotherapy-like hormonal treatments slowed disease progression by blocking all pathways that produce male hormones.
The study enrolled 1,145 patients with metastatic hormone-sensitive prostate cancer (mHSPC). Novartis said the combination of Pluvicto with the existing standard of care—combining androgen-deprivation therapy with an androgen receptor inhibitor—reduced the risk of disease progression or death by 28% versus standard care alone and extended survival. The complete response rate, meaning the disappearance of cancer cells, was 57.1% in the Pluvicto combination group and 42.3% in the standard-care group.
Korean institutions including Seoul National University Hospital, Severance Hospital, and Asan Medical Center also participated in the study. Scott Tagawa, a professor at Cornell University in the United States who led the research, said, "The Pluvicto combination delayed disease progression with relatively few side effects." Sriram Aradhye, chief medical officer and head of development at Novartis, said, "We will complete regulatory filings within the year so more patients can benefit from treatment."
FutureChem, a Korean radiopharmaceutical company, also presented a poster at the congress with domestic phase 2 dose-measurement data for the prostate cancer therapy FC705. The core of the study was confirming safety by analyzing organ-specific radiation absorption changes by the number of FC705 administrations.
There had been concerns about safety because FC705's circulation time in the body is long. The company said the study confirmed that, even with repeat dosing, organ-specific absorbed radiation doses remained stably below safety thresholds.
FutureChem said, "Safety concerns have been effectively resolved," and added, "We are proceeding with Institutional Review Board (IRB) reviews at Seoul National University Hospital and Seoul St. Mary's Hospital for a conditional domestic marketing authorization application for FC705 and first patient dosing in phase 3."