ASCO24: Novartis' Kinase Inhibitor Excels in Phase III Leukemia Trial

7 June 2024

The annual meeting of the American Society of Clinical Oncology (ASCO) opened Friday in Chicago, featuring more than 5,000 abstracts showcasing investigational therapies for various cancers. Anticipation is particularly high for a new bispecific antibody, antibody-drug conjugates (ADCs), and a BCMA-targeted CAR-T cell therapy.

Novartis' Scemblix Shines in Phase III Leukemia Trial

During the ASCO conference, Novartis reported promising results from its Phase III trial for Scemblix, a kinase inhibitor developed for chronic myeloid leukemia (CML). In the ASC4FIRST trial, Scemblix was tested against current standard-of-care tyrosine kinase inhibitors (TKIs). The results were impressive: 68% of patients receiving Scemblix achieved a major molecular response, compared to 49% in the TKI control group. Additionally, 39% of those on Scemblix experienced a deep molecular response, which is often considered a remission, compared to 21% in the comparison arms that included Novartis’ own Gleevec.

Scemblix was crafted to offer high potency and specificity with fewer side effects. This goal appears to have been met, as 86% of patients continued on Scemblix by the study's cutoff date, compared to 62% for Gleevec and 75% for a second-generation TKI.

Gilead's Trodelvy Faces Setback in Lung Cancer Trial

In less favorable news, Gilead Sciences shared more details about the failure of its antibody-drug conjugate, Trodelvy, in a Phase III trial for non-small cell lung cancer (NSCLC). Initially announced in January, the EVOKE-01 trial results revealed that Trodelvy did not achieve the primary endpoint of overall survival improvement.

During the ASCO meeting, Gilead disclosed that Trodelvy reduced the risk of death by 16% compared to the chemotherapy drug docetaxel. The median survival advantage for patients on Trodelvy was modest, at only 1.3 months. However, a subset of patients whose tumors did not respond to previous anti-PD(L)1 therapies showed a more notable survival benefit: 11.8 months for Trodelvy compared to 8.3 months for docetaxel.

Safety data also favored Trodelvy, with fewer grade 3 or worse adverse events and fewer treatment discontinuations due to toxicities compared to chemotherapy. Luis Paz-Ares, head of the medical oncology service at Hospital Universitario 12 de Octubre in Madrid, described the findings as encouraging, especially for patients with a significant unmet need. He emphasized the importance of further investigation despite the trial’s overall lack of success.

Anticipated Highlights

As ASCO continues, the medical community eagerly awaits additional data and announcements, particularly new developments in bispecific antibodies, ADCs, and BCMA-targeted CAR-T therapies. These cutting-edge treatments represent significant advancements in oncology, promising new hope for patients battling various malignancies.

Stay connected with BioSpace for the latest updates and in-depth coverage of the key findings and announcements from ASCO's annual meeting.

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