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北京时间·🕒 发布 18:32:21时区推断·⟳ 抓取 18:35:45·⚡ 决策 07-27 18:37:52 +2m07s·92.3 天前
Kura Oncology披露darlifarnib联合cabozantinib在肾癌Phase 1a更新数据
本次ORR 33%–50%、中位PFS 13个月属于正面临床信号，但仍是Phase 1a、小样本且后续仅进入随机Phase 1b剂量优化。
📄 原文KURA↗ 原文
Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal…
不做 Kura Oncology（KURA.US）
不做：本次是早期Phase 1a更新且同项目积极叙事已多次披露，注册性研究要到2028年，盘前价格未确认利好，缺少可执行的短线正期望。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
消息传播链
- 公司在ESMO 2025已披露FIT-001中darlifarnib联合cabozantinib在RCC的初步活性，ORR区间和安全性叙事已有旧基础。
- 公司此前已公布cabozantinib既往治疗患者子集数据，显示44% ORR和94% DCR，证明FIT-001活性叙事并非首次出现。
- 公司预告将在KCRS 2026展示cabozantinib-naive RCC患者的Phase 1a长期随访更新，并说明随机Phase 1b进行中、注册性研究计划2028年。
- 公司预告的KCRS口头报告时点，实际数据大概率在该会议报告中首次面对专业受众披露。
- 公司新闻稿披露ORR 33%–50%、中位PFS 13个月、Phase 1b继续推进等更新结果。市场反应:Futu显示KURA.US盘前/最新价10.39美元，较前收10.45美元下跌0.57%，未见利好即时确认。
关键理由
- 本次ORR 33%–50%、中位PFS 13个月属于正面临床信号，但仍是Phase 1a、小样本且后续仅进入随机Phase 1b剂量优化。
- 公司当前商业收入主要来自KOMZIFTI，Q1 2026净产品收入580万美元；darlifarnib本次RCC数据尚无可商业化收入，注册性研究计划到2028年，短期业绩增量为零。
- 该项目和KCRS展示已在7月14日预告，4月和2025年ESMO已有同机制/同试验积极数据，盘前报价10.39美元、较前收-0.57%，未见市场正向重定价确认。
主要风险
- 若8:00 ET投资者会给出未在新闻稿中的剂量选择、注册路径或监管沟通细节，可能重新形成单独催化。
- 早期肿瘤临床数据波动大，Phase 1a非随机数据与历史对照比较不足以直接推导商业成功。
反向证据
- 做多前查反向 · 来源 web · 日期 2025-10-20 · 影响 weakens
同一FIT-001项目和ORR区间此前已在ESMO 2025披露，削弱本次作为全新临床突破的预期差。
检索:Kura Oncology darlifarnib cabozantinib renal cell carcinoma FIT-001 previous data 2025 2026 原文 ↗ - 做多前查反向 · 来源 web · 日期 2026-07-14 · 影响 weakens
7月14日公司已预告7月24日KCRS更新报告，市场有时间提前知道数据窗口。
检索:Kura Oncology darlifarnib cabozantinib FIT-001 phase 1a RCC July 27 2026 原文 ↗ - 做多前查反向 · 来源 kb_search · 影响 none
内部KB未命中针对KURA/FIT-001的有效研报或付费纪要，未发现能把早期数据升级为高确定性商业化催化的增量证据。
检索:Kura Oncology darlifarnib cabozantinib renal cell carcinoma FIT-001 - 做多前查反向 · 来源 stock_quote · 日期 2026-07-27 · 影响 weakens
KURA.US最新10.39美元、较前收-0.57%，5日-4.33%、20日+0.29%，盘前未出现正向价格确认。
检索:KURA.US full quote premarket price market cap recent trend
工具调用 · 历史记录,结果未知(3 种)
- search_processed_events · 结果未知
- stock_quote · 结果未知
- kb_search · 结果未知
原文全文
展开原文 · 7,999 字
Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026
Content Import
07-27-2026
Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026
07-27-2026
General
– Response rates up to 50% across evaluated dose levels and median PFS of 13 months observed in pre-treated, cabozantinib-naïve, locally advanced or metastatic ccRCC patients –
– Activity compares favorably with historical outcomes for TKI and HIF-2 α monotherapies -–
– Combination was well tolerated and safety profile consistent with reported profiles of the individual agents –
– Findings support potential for darlifarnib to enhance activity of VEGFR-targeted therapies in second- and third-line RCC settings –
– Global, randomized Phase 1b study underway to establish recommended Phase 3 dose –
– Investor call scheduled for today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET –
SAN DIEGO, July 27, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, announced updated Phase 1a results from the ongoing FIT-001 clinical trial ( NCT06026410) demonstrating encouraging and durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). The results were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston and support continued development of the combination, including dose selection for the randomized Phase 1b portion of the study.
The long-term data compare favorably with benchmarks for advanced RCC, showing robust antitumor activity with darlifarnib plus cabozantinib, as well as evidence of durable benefit. The combination had a manageable safety profile across all dose levels, including when administered with full-dose cabozantinib.
Clinical Activity in Cabozantinib-naïve ccRCC Patients (N=34):
Objective response rate ranged from 33% to 50% across evaluated darlifarnib dose levels
Median progression free survival was 13 months across pooled dose levels
Median duration of response was not estimable at most dose levels assessed because multiple responses remain ongoing
Durable clinical benefit was observed across all evaluated combination dose levels, with more than half of patients remaining on treatment at data cut-off
Safety and Tolerability in RCC Patients (N=72):
The safety and tolerability profile was manageable and generally consistent with reported safety profiles of the individual agents
Supportive care, including for neutropenia, was not allowed during the dose-limiting toxicity study period
Neutropenia was successfully managed with dose interruption/reduction and supportive care (as allowed after the initial dose-limiting toxicity period)
“The response rates and progression-free survival observed with darlifarnib plus cabozantinib are encouraging in this refractory, pretreated, cabozantinib-naïve population, particularly given the limited treatment options after prior immunotherapy, immune check point inhibitors, and VEGFR-targeted therapy,” said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology, Assistant Medical Director Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. “Continued follow-up will further define the durability of benefit.”
Duration of Treatment and Clinical Outcomes
Clinical benefit observed across combination dose levels, with multiple patients remaining on treatment.
“These updated Phase 1a data continue to support the potential for darlifarnib to enhance VEGFR-targeted therapy in advanced RCC and have informed the dose combinations advancing into the randomized Phase 1b portion of FIT-001,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Cabozantinib-naïve patients represent an increasingly important treatment population as cabozantinib is often reserved for later lines of therapy following immunotherapy-based regimens. We look forward to longer follow-up from Phase 1a and randomized data from Phase 1b as we continue development toward a planned registrational study.”
Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory ccRCC. The Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a planned registrational study in 2028.
Virtual Investor Event
Kura will host a webcast and conference call today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Assistant Medical Director, Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.
Abbreviations
HIF-2α, hypoxia-inducible factor 2 alpha; PD, progressive disease; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma; SD, stable disease; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptor
About Darlifarnib
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) under development that inhibits farnesylation of RHEB, resulting in selective mTORC1 inhibition while sparing mTORC2. This mechanism has potential to enhance the activity of multiple targeted therapies where complementary inhibition of oncogenic pathways may improve clinical outcomes, including VEGFR-targeted therapies such as cabozantinib.
About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI ® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1 -mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn .
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of darlifarnib to enhance the activity of cabozantinib and other VEGFR-targeted therapies in RCC and to improve clinical outcomes, the potential of darlifarnib in combination with cabozantinib to offer durable benefit to patients with RCC, and ongoing and planned clinical trials of darlifarnib in combination with cabozantinib. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a
Content Import
07-27-2026
Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026
07-27-2026
General
– Response rates up to 50% across evaluated dose levels and median PFS of 13 months observed in pre-treated, cabozantinib-naïve, locally advanced or metastatic ccRCC patients –
– Activity compares favorably with historical outcomes for TKI and HIF-2 α monotherapies -–
– Combination was well tolerated and safety profile consistent with reported profiles of the individual agents –
– Findings support potential for darlifarnib to enhance activity of VEGFR-targeted therapies in second- and third-line RCC settings –
– Global, randomized Phase 1b study underway to establish recommended Phase 3 dose –
– Investor call scheduled for today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET –
SAN DIEGO, July 27, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, announced updated Phase 1a results from the ongoing FIT-001 clinical trial ( NCT06026410) demonstrating encouraging and durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). The results were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston and support continued development of the combination, including dose selection for the randomized Phase 1b portion of the study.
The long-term data compare favorably with benchmarks for advanced RCC, showing robust antitumor activity with darlifarnib plus cabozantinib, as well as evidence of durable benefit. The combination had a manageable safety profile across all dose levels, including when administered with full-dose cabozantinib.
Clinical Activity in Cabozantinib-naïve ccRCC Patients (N=34):
Objective response rate ranged from 33% to 50% across evaluated darlifarnib dose levels
Median progression free survival was 13 months across pooled dose levels
Median duration of response was not estimable at most dose levels assessed because multiple responses remain ongoing
Durable clinical benefit was observed across all evaluated combination dose levels, with more than half of patients remaining on treatment at data cut-off
Safety and Tolerability in RCC Patients (N=72):
The safety and tolerability profile was manageable and generally consistent with reported safety profiles of the individual agents
Supportive care, including for neutropenia, was not allowed during the dose-limiting toxicity study period
Neutropenia was successfully managed with dose interruption/reduction and supportive care (as allowed after the initial dose-limiting toxicity period)
“The response rates and progression-free survival observed with darlifarnib plus cabozantinib are encouraging in this refractory, pretreated, cabozantinib-naïve population, particularly given the limited treatment options after prior immunotherapy, immune check point inhibitors, and VEGFR-targeted therapy,” said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology, Assistant Medical Director Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. “Continued follow-up will further define the durability of benefit.”
Duration of Treatment and Clinical Outcomes
Clinical benefit observed across combination dose levels, with multiple patients remaining on treatment.
“These updated Phase 1a data continue to support the potential for darlifarnib to enhance VEGFR-targeted therapy in advanced RCC and have informed the dose combinations advancing into the randomized Phase 1b portion of FIT-001,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Cabozantinib-naïve patients represent an increasingly important treatment population as cabozantinib is often reserved for later lines of therapy following immunotherapy-based regimens. We look forward to longer follow-up from Phase 1a and randomized data from Phase 1b as we continue development toward a planned registrational study.”
Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory ccRCC. The Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a planned registrational study in 2028.
Virtual Investor Event
Kura will host a webcast and conference call today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Assistant Medical Director, Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.
Abbreviations
HIF-2α, hypoxia-inducible factor 2 alpha; PD, progressive disease; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma; SD, stable disease; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptor
About Darlifarnib
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) under development that inhibits farnesylation of RHEB, resulting in selective mTORC1 inhibition while sparing mTORC2. This mechanism has potential to enhance the activity of multiple targeted therapies where complementary inhibition of oncogenic pathways may improve clinical outcomes, including VEGFR-targeted therapies such as cabozantinib.
About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI ® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1 -mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn .
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of darlifarnib to enhance the activity of cabozantinib and other VEGFR-targeted therapies in RCC and to improve clinical outcomes, the potential of darlifarnib in combination with cabozantinib to offer durable benefit to patients with RCC, and ongoing and planned clinical trials of darlifarnib in combination with cabozantinib. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a
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