ASCO 2025 is in full swing, with Eli Lilly and Company presenting new data on several investigational drugs at this year's conference, including Imlunestrant.(Oral Selective ER Degrader)、Olomorasib(KRAS G12C Inhibitor)、LY4170156 （FRα ADC）And abemaciclib(CDK4/6 Inhibitor)。
This article will select some for specific introduction, for readers' reference.*Due toWenDue to limited space, it is difficult to include all important research results. Welcome to use the Insight database for reference (Long press the QR code at the end of the article).Free TrialOh~).
Product: Imlunestrant
Molecular Mechanism: ER Degrader
Registration Number: NCT04975308, NCT04975308
Presentation Type: Oral Presentation, Poster
Abstract No.: 1001, 1060
Screenshot source: ASCO official websiteAt this year's ASCO conference, Eli Lilly and Company announced a study on Imlunestrant treatment.ER+/HER2- Advanced Breast CancerThe results of the Phase III clinical trial EMBER-3. Among them, the patient-reported outcomes will be announced in the form of an oral presentation, and the safety data will be presented in the form of a poster.The study randomly assigned patients in a 1:1:1 ratio to receive Imlunestrant monotherapy, Imlunestrant + abemaciclib, or standard therapy.(SOC, fulvestrant or exemestane)Treatment. The primary endpoint of the study is PFS.The results showed that, for patients with ESR1 mutations,Imlunestrant monotherapy significantly improved PFS, correlating with quality-of-life scales for many cancer patients.（EORTC QLQ-C30）Improvement or maintenance of scores, while the standard therapy（SOC）The score decreased or remained stable. Specifically, for patients with ESR1 mutations using Imlunestrant,Overall Health Status (GHS)/Quality of Life (QOL) And physical function (PF) Scores have improved., while the SOC score decreased.(Mean difference in change: 9.9 and 6.2, respectively)。In the overall population, the decline in GHS/QOL scores was similar between Imlunestrant and SOC.(Mean difference change: 0.5), while the PF score for Imlunestrant remains unchanged, and the SOC slightly decreases.(Mean difference change: 2.5)Imlunestrant + Abemaciclib group and Imlunestrant group showed a roughly similar declining trend in all patients, with minor differences in the mean changes of GHS/QOL and PF scores.(0.8 and -2.2, respectively)。In terms of the safety of the poster presentation, a total of 859 patients were included.(Imlunestrant: 327, SOC: 324, and Imlunestrant + Abemaciclib: 208)Imlunestrant demonstrated a favorable safety profile, similar to SOC, with predominantly grade 1 adverse events. The safety of Imlunestrant + Abemaciclib was consistent with the known profile of Abemaciclib, with no overlapping toxicities. Adverse events were manageable with supportive medications and/or dose adjustments, resulting in very few patients discontinuing treatment across all groups.Screenshot source: ASCO official website
Product: Olomorasib
Molecular Mechanism: KRAS G12C Inhibitor
Registration Number: NCT04956640, NCT04956640
Presentation Type: Oral Presentation, Rapid Oral Presentation
Abstract No.: 3507, 8519
At this conference, Eli Lilly presented the latest results of the Olomorasib Phase I/II clinical study through two oral presentations, respectively showcasing Olomorasib combined with pembrolizumab for the treatment of KRAS G12C-mutated advanced non-small cell lung cancer. (NSCLC) Patients, and the combination of cetuximab for the treatment of KRAS G12C-mutated colorectal cancer (CRC) The patient's two-part study data.Screenshot source: ASCO official websiteAs of November 13, 2024, 93 patients had received Olomorasib + Cetuximab dose escalation/expansion.（n=49）Or optimize（n=44）Treatment, with a median of 3 prior treatment lines.The median duration of combination therapy was 6.5 months., 32 patients are still receiving treatment. The specific efficacy is shown in the table below.Screenshot source: ASCO official websiteIn terms of safety, all-grade TRAEs occurring in ≥20% of patients included acneiform dermatitis, diarrhea, dry skin, paronychia, hypomagnesemia, and rash. Most TRAEs were grade 1-2, with ≥grade 3 TRAEs occurring in 24% of patients. The most common ≥grade 3 TRAEs were diarrhea, hypokalemia, and rash, each occurring in 2 patients. TRAEs led to dose reduction of Olomorasib in 2% of patients, maintenance of Olomorasib dose in 22% of patients, and maintenance of cetuximab dose in 16% of patients. Among the 61 patients who discontinued treatment, 57 did so due to PD. Two patients discontinued cetuximab due to TRAEs and continued on Olomorasib. Adverse reactions were similar across different doses. Non-Small Cell Lung CancerScreenshot source: ASCO official websiteAs of November 13, 2024, a total of 43 patients had received Olomorasib in combination with Pembrolizumab in first-line treatment.（50 mg，n=21；100 mg，n=22）Treatment, including 10 cases with PD-L1 negative, 13 cases with PD-L1 expression 1-49%, 19 cases with PD-L1 expression ≥50%, and 1 case unknown. The median follow-up time was 5.5 months.As of the data cutoff, 33 patients were still receiving treatment, and 10 patients had discontinued treatment. Among the 40 patients evaluable for efficacy, the median follow-up time was 9 months.Patients with all levels of PD-L1 expression ORR is 70%(1 case of CR, 23 cases of PR, 4 cases of unconfirmed PR pending/in progress)，DCR is 90%。In patients with PD-L1 ≥50%, the ORR was 82% and the DCR was 94%.. The median duration of response has not been reached,The 6-month PFS rate was 80%.。In terms of safety, all-grade TRAEs occurring in ≥10% of patients included increased ALT/AST, diarrhea, fatigue, nausea, pruritus, and decreased appetite; grade 3 TRAEs occurring in ≥10% of patients included increased ALT/AST. Liver events were generally manageable with dose adjustments and/or the use of corticosteroids. No patients experienced concurrent elevation of total bilirubin or discontinued both study treatments due to liver events. Pneumonitis was reported in two patients.(Grade 2 and Grade 4)The AE profiles were generally similar across dose levels. TRAE led to dose reduction of Olomorasib in 16% of patients and discontinuation of the combination therapy in 5% of patients.Molecular Mechanism: FRα ADCRegistration Number: NCT06400472
Display Type: Poster
Abstract No.: 3023
Screenshot source: ASCO official websiteAt this conference, Eli Lilly and Company presented LY4170156.Platinum-Resistant Ovarian CancerMulticenter, open-label, conducted in patientsFor the first timePreliminary Results of Phase Ia/Ib Clinical Studies in Humans.As of November 27, 2024, 45 patients have been treated with LY4170156, 32 of whom have high-grade serous ovarian cancer. (HGSOC)In HGSOC patients, the median number of prior treatment lines was 5, and 19% of patients had received mirvetuximab soravtansine.（FRα ADC）Treatment: 44% of patients were found to have FRα expression < 75% through local or central testing.In 13 evaluable patients with HGSOC(6 cases FRα ≥75%; 6 cases <75%; 1 case data pending)，9 cases showed a reduction in target lesions; preliminary ORR was 38%.（n = 5）, 1 case of CR, 4 cases of PR, and 4 cases of SD at all dose levels.4 and 6 mg/kg dose levelsOverall ORR was 55%At the time of data cutoff, all responses were unconfirmed and ongoing. Of the 5 responders, 3 had FRa expression < 75%, and 2 had ≥75%, including one who was refractory to mirvetuximab soravtansine.In terms of safety, the most common treatment-emergent adverse events at all dose levels（TEAE；≥15%）For nausea, fatigue, anemia, vomiting, diarrhea, and neutropenia. Three patients experienced febrile neutropenia. To date, no pulmonary or ocular toxicity has been observed. Two cases of DLT were noted; the MTD has not been determined to date.Screenshot source: Insight databaseCover Source:Insight Database ChartDisclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If you have any needs, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
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