“The five studies presented during the Plenary Session at ASCO 2026 all provide robust clinical evidence with the potential to change the standard of care. The only exception is the ivonescimab study, which was conducted exclusively in China.”

Dr. Hanlim Moon, CEO of MediRama, made these remarks during the MediRama Highlights ASCO 2026 seminar held on July 16 at Yuhan Corporation's headquarters in Seoul. Now in its fourth year, the annual seminar reviews and interprets the most impactful studies presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Dr. Moon emphasized that data presented at ASCO extend far beyond academic achievement, often serving as a catalyst for changes in clinical practice and oncology drug development strategies. Major clinical findings presented at ASCO are frequently published simultaneously in leading medical journals and subsequently incorporated into clinical practice guidelines issued by organizations such as the National Comprehensive Cancer Network (NCCN) and ASCO, while also informing regulatory reviews by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

During the seminar, Dr. Moon reviewed the clinical significance of five landmark studies presented in the ASCO 2026 Plenary Session:

• LBA1 (PROTEUS): Johnson & Johnson's Phase III study of ERLEADA® (apalutamide) in localized prostate cancer.

• LBA2 (SARC041): Eli Lilly's Phase III study of Verzenio® (abemaciclib) in dedifferentiated liposarcoma (DDLPS).

• LBA3 (LIBRETTO-432): Eli Lilly's Phase III study evaluating Retevmo® (selpercatinib) as adjuvant therapy for RET fusion-positive non-small cell lung cancer (NSCLC).

• LBA4 (HARMONi-6): Akeso's Phase III study of the PD-1/VEGF bispecific antibody ivonescimab in squamous NSCLC.

• LBA5 (RASolute 302): Revolution Medicines' Phase III study of daraxonrasib, a RAS inhibitor, in pancreatic cancer.

Dr. Moon began by discussing the PROTEUS trial, which enrolled 2,109 patients with newly diagnosed high-risk localized or locally advanced prostate cancer. Patients were randomly assigned to receive either apalutamide plus androgen deprivation therapy (ADT) (n=1,057) or placebo plus ADT (n=1,052).

The study demonstrated that the apalutamide plus ADT arm reduced the risk of metastasis or death by 20% compared with the control arm. Pathologic complete response (pCR) or minimal residual disease rates also differed substantially between the treatment and control groups (8.9% vs. 1.0%, respectively).

Commenting on the use of pCR as an endpoint, Dr. Moon noted: "Pathologic complete response has not traditionally been regarded as a standard endpoint in prostate cancer, so its clinical significance has been debated. However, improvements were also observed in other clinically meaningful endpoints, including metastasis-free survival and time to subsequent therapy, suggesting that these findings may influence future clinical practice."

Dr. Moon also highlighted the results of the abemaciclib study in well-differentiated and dedifferentiated liposarcoma.

The trial demonstrated a median progression-free survival (PFS) of 9.67 months with abemaciclib compared with 1.52 months in the placebo group, representing a 61% reduction in the risk of disease progression or death. These outcomes substantially exceeded those reported for currently approved therapies, which typically provide a median PFS of approximately two months.

According to Dr. Moon, the findings underscore the therapeutic potential of CDK4/6 inhibitors in rare sarcomas, a disease setting where conventional chemotherapy has historically produced limited clinical benefit.

Turning to the LIBRETTO-432 study, which evaluated selpercatinib as adjuvant therapy for RET fusion-positive NSCLC, Dr. Moon described it as "another targeted therapy entering the early-stage lung cancer treatment landscape."

While very few recurrences were observed among patients receiving selpercatinib, recurrences continued to accumulate in the placebo arm throughout follow-up.

"Following osimertinib for EGFR-mutated lung cancer and alectinib for ALK-positive disease, RET fusion-positive lung cancer has now gained another targeted therapy in the adjuvant setting," Dr. Moon said. "The treatment paradigm is shifting toward introducing highly effective targeted therapies earlier in the disease course to increase the likelihood of cure."

Regarding the HARMONi-6 trial evaluating the PD-1/VEGF bispecific antibody ivonescimab, Dr. Moon acknowledged that the study demonstrated an improvement in overall survival (OS) but cautioned against assuming immediate adoption as a global standard of care.

She noted that discussion during the ASCO meeting focused on two important limitations: the study enrolled only Chinese patients, and the comparator arm used tislelizumab, rather than pembrolizumab, which is considered the global standard of care. These factors, he explained, raise questions regarding the generalizability of the findings to broader international populations.

Among the five studies, Dr. Moon identified the RASolute 302 trial of daraxonrasib in pancreatic cancer as the most remarkable.

Daraxonrasib is the first investigational agent in a new class of RAS(ON) multi-selective inhibitors, designed to target a broad range of RAS mutations.

Patients treated with daraxonrasib achieved a median overall survival (mOS) of 13.2 months, nearly doubling survival compared with conventional chemotherapy, which yielded a median overall survival of 6.6–6.7 months.

"The response from the audience during the daraxonrasib presentation was extraordinary," Dr. Moon recalled.

Beyond improving overall survival, daraxonrasib nearly doubled progression-free survival (PFS) and produced an objective response rate approximately three times higher than that observed with chemotherapy. "In pancreatic cancer, where therapeutic progress has remained limited for nearly two decades, improvements of this magnitude are highly meaningful for clinicians," she said. "Daraxonrasib has strong potential to become a new standard of care, and its development is likely to expand into first-line therapy, combination regimens, and the adjuvant setting."

Concluding her presentation, Dr. Moon emphasized: "All five studies presented this year demonstrated robust and credible clinical evidence. Most are likely to influence future clinical practice guidelines and regulatory decision-making, while also establishing new benchmarks that oncology drug developers around the world will need to meet."

Source : “ASCO 2026, 표준치료 변화 예고”…문한림 메디라마 대표가 짚은 연구 ‘5건’ < 기업·일반 < 기사본문 - 더바이오 (THE BIO)