Alpelisib

– KOMET-001 registrational trial in R/R NPM1-mutant AML achieved primary endpoint – – Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline intensive chemotherapy trial – – Topline MRD-negative CR results from KOMET-017-IC Phase 3 trial anticipated in 2028 – – Multiple data presentations for ziftomenib and pipeline programs expected throughout 2025 – – $727.4 million in cash, together with anticipated collaboration agreement payments, to support ziftomenib commercialization through the frontline AML combination setting – – Management to host webcast and conference call today at 4:30 p.m. ET – SAN DIEGO , Feb. 26, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported fourth quarter and full year 2024 financial results and provided a corporate update. “We are very pleased the KOMET-001 registrational trial achieved its primary endpoint. We look forward to sharing topline data at an upcoming medical conference and expect to submit a New Drug Application (NDA) in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML) next quarter,” said Troy Wilson , Ph.D., J.D., President and Chief Executive Officer of Kura Oncology . “In parallel, we are advancing ziftomenib into registrational studies in the frontline (1L) setting. Approximately half of patients with newly diagnosed NPM1-mutated (NPM1-m) AML and 80% of patients with KMT2A-rearranged (KMT2A-r) AML will die from the disease within five years. Given this unmet need, we are pleased to have reached alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on key aspects of our Phase 3 trials, including the use of minimum residual disease (MRD)-negative complete response (CR) as a primary endpoint for potential accelerated approval in the U.S. , with topline results anticipated in 2028. Our KOMET-017 trial is breaking new ground, and we and our partners at Kyowa Kirin are working as rapidly as possible to bring ziftomenib to AML patients worldwide.” Recent Highlights Positive topline results from registration-directed trial of ziftomenib in R/R NPM1-m AML – Kura and Kyowa Kirin announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib in patients with R/R NPM1-m AML. The KOMET-001 trial achieved its primary endpoint, consistent with the targeted 20-30% CR/CR with partial hematological recovery (CRh) rate, and data have been submitted for presentation at ASCO. The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports. Facilitated by the Breakthrough Therapy Designation status of ziftomenib in R/R NPM1-m AML, the Company completed its pre-NDA meeting with FDA and anticipates submitting an NDA in the second quarter of 2025. Positive feedback from FDA for 1L combination trial designs – Earlier this month, Kura and Kyowa Kirin announced alignment with FDA on the KOMET-017 global trial protocol evaluating ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and/or KMT2A-r AML. This includes alignment on potential pathways for accelerated approval in the U.S. in both the KOMET-017-IC (intensive chemotherapy) and KOMET-017-NIC (non-intensive chemotherapy) trials by allowing the trials to use MRD-negative CR and CR, as primary endpoints, respectively. The companies also gained alignment with the EMA on the KOMET-017 protocol, and expect to initiate the KOMET-017 Phase 3 trials in the second half of 2025. Positive clinical data for Phase 1 trial of ziftomenib in combination with standards of care – In December 2024 , Kura Oncology and Kyowa Kirin announced encouraging clinical data from KOMET-007, a Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine/daunorubicin (7+3) and venetoclax/azacitidine in patients with NPM1-m and KMT2A-r AML. Among response-evaluable patients enrolled in the 7+3 combination cohort for patients with 1L NPM1-m or KMT2A-r adverse risk AML, 91% achieved a CR (100% for NPM1-m, 83% for KMT2A-r patients). Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the trial. The positive results from KOMET-007 reported at ASH reinforce the companies’ commitment to evaluating ziftomenib across the continuum of 1L AML treatment options. Global strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib in acute leukemias – In November 2024 , Kura Oncology and Kyowa Kirin announced they entered into a global strategic collaboration to develop and commercialize ziftomenib (Kyowa Agreement), funding the expansive AML development program through U.S. commercialization in 1L combinations. Under the partnership, Kura retains leadership and key strategic rights to ziftomenib in the U.S. and preserves strategic flexibility, while enabling development and commercialization of ziftomenib across the continuum of care in acute leukemias, including both fit and unfit 1L indications, post-transplant maintenance setting and combinations with targeted therapies. Preclinical data supporting opportunity for ziftomenib in treatment of gastrointestinal stromal tumors (GIST) – In October 2024 , Kura reported preclinical data presented at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona , supporting the potential for ziftomenib in combination with KIT inhibitors for GIST patients. The combination of ziftomenib and imatinib demonstrated robust and durable antitumor activity in imatinib-sensitive (1L) and imatinib-resistant (2L/3L) GIST patient-derived xenograft models. Sixty percent of patients develop resistance to imatinib within two years and ziftomenib has the potential to delay the onset of resistance to, or overcome resistance in patients pre-treated with, imatinib. In August 2024 , Kura announced clearance by the FDA of an IND application and the Company remains on track to initiate the KOMET-015 trial evaluating ziftomenib plus imatinib in patients with advanced GIST, in the first half of 2025. Clinical and preclinical data support combinations of farnesyl transferase inhibitors with targeted therapies – Despite multiple advances, innate and adaptive resistance remain a challenge for many classes of targeted therapies in cancer. A growing body of clinical and preclinical data demonstrates the potential of farnesyl transferase inhibitors as companion therapeutic agents to augment the antitumor activities of various targeted therapies and overcome resistance in combination. Enrollment in the FIT-001 trial evaluating our next-generation farnesyl transferase inhibitor KO-2806 continues to progress and the dose-escalation portion of the KURRENT-HN trial with tipifarnib is now complete. Kura expects to present the first clinical data for KO-2806 as a monotherapy and in combination, as well as clinical data from the KURRENT-HN trial, in the second half of 2025. Financial Results Collaboration revenue from our Kyowa Kirin partnership for the fourth quarter and full year 2024 was $53.9 million , compared to no revenue in 2023. Research and development (R&D) expenses for the fourth quarter of 2024 were $52.3 million , compared to $32.5 million for the fourth quarter of 2023. R&D expenses for the full year 2024 were $170.0 million , compared to $115.2 million for the prior year. General and administrative (G&A) expenses for the fourth quarter of 2024 were $24.1 million , compared to $14.2 million for the fourth quarter of 2023. G&A expenses for the full year 2024 were $77.1 million , compared to $50.6 million for the prior year. Net loss for the fourth quarter of 2024 was $19.2 million , compared to a net loss of $42.8 million for the fourth quarter of 2023. Net loss for the full year 2024 was $174.0 million , compared to a net loss of $152.6 million for the prior year. Net loss for the fourth quarter and full year 2024 included non-cash, share-based compensation expense of $8.6 million and $33.9 million , respectively. This compares to $7.2 million and $28.1 million for the same periods in 2023. As of December 31, 2024 , Kura had cash, cash equivalents and short-term investments of $727.4 million , including the upfront payment of $330.0 million from Kyowa Kirin, compared to $424.0 million as of December 31, 2023 . Based on our current plans, we believe our cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient to enable us to fund our current operating expenses into 2027, and combined with anticipated collaboration funding under the Kyowa Agreement, should support our ziftomenib AML program through commercialization in the 1L combination setting. Forecasted Milestones Submit an NDA for ziftomenib in R/R NPM1-m AML in the second quarter of 2025. Present topline data from KOMET-001 Phase 2 registration-directed trial in R/R NPM1-m AML in the second quarter of 2025. Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with intensive chemotherapy (7+3) at a medical meeting in the second quarter of 2025. Initiate the KOMET-015 trial evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025. Initiate two independent Phase 3 registration-enabling trials in 1L intensive (KOMET-017-IC) and non-intensive (KOMET-017-NIC) AML in the second half of 2025. Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with venetoclax and azacitidine at a medical meeting in the second half of 2025. Nominate a development candidate for next-generation menin inhibitor program in diabetes in mid-2025. Initiate one or more expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the first half of 2025. Present data from the Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS mutations in the second half of 2025. Present data from the Phase 1 trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma in the second half of 2025. Present data from the dose escalation portion of KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) in the second half of 2025. Conference Call and Webcast Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, February 26, 2025 , to discuss the financial results for the fourth quarter and full year 2024 and to provide a corporate update. The live call may be accessed by dialing (800) 579-2543 for domestic callers and (785) 424-1789 for international callers and entering the conference ID: KURAQ4. A live webcast and archived replay of the event will be available here or online from the investor relations section of the company website at www.kuraoncology.com. About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates targeting cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the FDA for the treatment of R/R NPM1-m AML. In November 2024 , Kura Oncology entered a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML has been completed, and the companies anticipate submission of an NDA to the FDA in the second quarter of 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-r AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC. For additional information, please visit Kura’s website at www.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 statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura’s product candidates, ziftomenib, tipifarnib and KO-2806; plans, trial designs and expected timing of clinical trials; the expected timing and presentation of results and data from clinical trials; the anticipated timing of submission of an NDA for ziftomenib; the potential for U.S. accelerated approval and full approval of product candidates; and the success and impact of interactions with the FDA; the potential for menin inhibitors to shift the treatment paradigm for GIST; the strength of Kura’s balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund its current operating plan to 2027, and combined with anticipated collaboration funding under the Kyowa Agreement, to support Kura’s ziftomenib AML program through commercialization in the 1L combination setting. 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, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, 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 business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission , which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Investors: Patti Bank Managing Director(415) 513-1284patti.bank@icrhealthcare.com Media: Alexandra Weingarten Associate Director, Corporate Communications (858) 500-8822alexandra@kuraoncology.com Source: Kura Oncology, Inc.

点击上方蓝字 关注我们 编者按：Inavolisib（伊那利塞）作为强效选择性p110α抑制剂，在针对PIK3CA突变的HR+/HER2-晚期乳腺癌治疗中展现出了新希望。GO39374（NCT03006172）为I/Ib期临床试验，探索了伊那利塞联合哌柏西利及内分泌治疗的安全性与初步疗效。结果揭示了该联合方案的安全可控性、良好耐受性及持久抗肿瘤活性，为III期INAVO120临床研究奠定了基础，本文特进行报道。 研究背景 HR+/HER2-乳腺癌是最常见的乳腺癌亚型，局部晚期或转移性乳腺癌（LA/mBC）的初始治疗包括单药内分泌治疗（ET）或与靶向治疗联合；例如，细胞周期依赖性激酶4/6抑制剂（CDK4/6i）。后续治疗方案包括ET单药或联合PI3K/AKT/mTOR通路抑制剂。随着原发性和获得性耐药的出现，现有疗法的临床获益仍然有限。因此，能够预防或克服对现有标准疗法耐药的更有效治疗方案至关重要。 PI3K/AKT/mTOR信号通路失调与原发和获得性内分泌耐药均有关。大约35%～40%的HR+乳腺癌患者携带PIK3CA突变，PIK3CA是编码PI3K复合体α亚型催化亚基（p110a）的基因。此外，在与ET和周期蛋白依赖性激酶4/6抑制剂（CDK4/6i）耐药相关的多种异常中，已发现生长因子信号传导通路（如PI3K/AKT/mTOR[PI3K]通路）的上调。这些相互连接的信号节点之间的串扰是乳腺癌疾病生物学特性和治疗反应的基础。在临床前模型中，同时抑制雌激素受体、CDK4/6和PI3K通路可在体内外产生细胞周期阻滞、凋亡和肿瘤消退的协同效应。 SOLAR-1将alpelisib（PI3Ka抑制剂）和氟维司群联合治疗确立为在内分泌治疗方案治疗期间或之后发生进展的PIK3CA突变、HR+/HER2-转移性乳腺癌（mBC）的标准治疗。然而，在临床实践中，由于其具有挑战性的安全性（导致较差的耐受性），这一联合用药方案的实施受到了限制。 伊那利塞是一种强效的选择性p110a抑制剂，可促进突变p110a的降解。在生化检测中，伊那利塞对p110a的选择性是对b、d和g亚型的300倍，并且在携带突变型p110a的肿瘤细胞中显示出比野生型p110a更高的效力。由于伊那利塞特异性地促进突变型p110a的降解，而不影响野生型p110α，因此内源性的p110α亚型及其维持体内平衡的下游效应分子得以保留，这可能有助于限制毒性。非临床研究表明，伊那利塞具有较高的安全界值，以及较强、较持久的靶向抑制作用和较好的体内疗效。此外，在PIK3CA突变的异种移植模型中，伊那利塞联合哌柏西利（palbociclib）和氟维司群（fulvestrant）的治疗方案相较于伊那利塞单药治疗，以及伊那利塞分别与哌柏西利或氟维司群联合治疗方案，展现出了更强的抗肿瘤疗效，这支持在临床试验中进一步探索伊那利塞、哌柏西利和ET的联合应用。 GO39374是一项首次在人体中进行的I/Ib期、开放性、剂量递增研究，旨在评估伊那利塞单药以及与ET和/或靶向治疗联合使用时，在PIK3CA突变的LA/mBC患者中的安全性、耐受性、药代动力学（PK）和初步抗肿瘤活性。本文报道了伊那利塞联合哌柏西利及ET治疗PIK3CA突变、HR+/HER2-LA/mBC的临床安全性和耐受性、药代动力学、初步抗肿瘤活性，以及对通路和病理生理生物标志物应答的分析。 研究方法 研究纳入了年龄≥18岁且携带PIK3CA突变的肿瘤患者。分别接受伊那利塞、哌柏西利和来曲唑（Inavo +Palbo+Letro组；来曲唑组）/氟维司群（Inavo+Palbo+Fulv组；氟维司群组）治疗，直至出现不可接受的毒性或疾病进展。评估来曲唑组在I期和II期剂量扩展阶段采用了3+1+3的剂量递增设计；而评估氟维司群组则在进行II期剂量扩展前设置了一个安全性导入期。 患者按剂量水平接受伊那利塞治疗（I期：3 mg、6 mg或9 mg；II期：9 mg），于每个28天周期的第1-28天（D1-28）每日一次口服（PO），同时于第1-21天（D1-21）每日一次口服哌柏西利（125 mg），以及于D1-28每日一次口服来曲唑（2.5 mg）；或在第1周期（C1）的第1天（D1）和第15天（D15）肌注氟维司群（500 mg），并从第2周期（C2）的第1天（D1）开始，大约每4周一次，于每个28天周期中给药。PIK3CA肿瘤突变状态通过针对肿瘤组织或血浆来源的循环肿瘤DNA（ctDNA）的定点局部聚合酶链反应（PCR）或二代测序检测，或者通过既往的留档信息确定。 主要终点是安全性和耐受性，通过总结不良事件（AEs）、实验室检查结果的变化以及生命体征的变化来评估；所有接受至少一次研究治疗的患者均纳入安全性分析。抗肿瘤活性的终点指标包括经确认的客观缓解、缓解持续时间、临床获益率以及无进展生存期（PFS）。 研究结果 截至2023年3月27日，来曲唑组（3 mg组5例，6 mg组5例，9 mg组7例）共入组13例患者进入I期研究。在II期研究中，来曲唑组和氟维司群组各入组20例患者（图1）。在两组患者中，患者的中位年龄分别为57岁和55岁；基线时ECOG体力状态（PS）评分为0的患者比例分别为60.6%和50.0%；大多数患者为白人（分别为78.8%和50.0%）。在转移性疾病设置中，患者中位既往系统治疗线数分别为2线（范围0-4线）和1线（范围0-4线）；既往接受过化疗的患者比例分别为78.8%和75.0%；既往接受过CDK4/6抑制剂治疗的患者比例分别为21.2%和0%；在来曲唑组和氟维司群组中，研究入组时分别有54.5%和30%的患者存在肝转移（表1）。 △ 图1. 患者入组流程图。（A）来曲唑组；（B）氟维司群组 表1. 基线人口统计学和既往抗癌治疗（安全性可评估人群） 来曲唑组和氟维司群组的中位伊那利塞治疗持续时间分别为15.7个月（范围：1.3-66.5个月）和20.8个月（范围：1.8-47.6个月）。来曲唑组和氟维司群组的中位伊那利塞累积剂量强度分别为95.3%和90.5%。 安全性 来曲唑组I期未报告剂量限制性毒性（DLT）。所有患者均至少发生一次与治疗相关的不良事件（TRAE），其中最常见（任一组中≥30%）的不良事件在来曲唑组和氟维司群组中分别为：口腔炎（66.7%和90%）、中性粒细胞减少（81.8%和85.0%）、高血糖（63.6%和70.0%）、腹泻（48.5%和55.0%）、血小板减少（48.5%和50.0%）、贫血（57.6%和45.0%）、恶心（45.5%和30.0%）（见表2）。来曲唑组和氟维司群组中，分别有87.9%和85%的患者发生任何3-4级TRAE，分别有15.2%和0%的患者发生严重TRAE；分别有93.9%和100%的患者因任何研究治疗的不良事件导致剂量调整（中断、减少或停药）；分别有18.2%和30.0%的患者因不良事件导致伊那利塞剂量减少。来曲唑组中有6.1%的患者因任何治疗的不良事件导致治疗中断，氟维司群组中有10.0%的患者因治疗的不良事件导致治疗中断。两组中均未发生死亡事件。 表2. 两组中最常见（≥30%）治疗相关不良事件（安全性可评估人群） 药代动力学 结果表明，伊那利塞单药组与伊那利塞联合用药组之间，按剂量归一化的给药后0至24小时稳态药时曲线下面积（AUC 0-24）和最低血药浓度（Cmin）相似，提示哌柏西利、来曲唑或氟维司群对伊那利塞的药代动力学（PK）无影响。 有效性 在基线时有可测量病灶的患者中，来曲唑组和氟维司群组分别有15例（60.0%）和6例（40.0%）患者获得了最佳总体缓解，即完全缓解（CR）或部分缓解（PR）。在这些患者中，确认的客观缓解率（ORR）分别为52.0%和40.0%；来曲唑组和氟维司群组的缓解持续时间分别为42.3个月（95%CI：14.7～NE）和11.9个月（95% CI：7.6～NE）。图2报告了可测量病灶患者肿瘤直径总和相较于基线的百分比变化及最佳总体缓解情况。 △图2. （疾病可测量的安全性可评估人群）中肿瘤直径总和（SLD）相较于基线的最佳变化百分比。 在全体患者人群中，来曲唑和氟维司群组的临床获益率分别为78.8%（26/33例）和90.0%（18/20例）。来曲唑组和氟维司群组的中位无进展生存期（PFS）分别为23.3个月（95% CI：9.2～44.4）和35.0个月（95% CI：17.7～NE）（见表3）。 表3. 疗效总结 讨论 ET仍然是HR+乳腺癌在早期和转移性情况下的治疗基石，并且现在已经发展到包括与靶向治疗的双药组合，如CDK4/6抑制剂和PI3K通路抑制剂。然而，雌激素受体（ER）、CDK4/6和PI3K通路之间的交互作用为针对三个或更多信号节点的更高阶组合提供了科学依据，以优化临床获益并模仿HER2阳性乳腺癌中类似组合的结果，包括曲妥珠单抗、帕妥珠单抗和多西他赛的联合治疗方案。 该研究数据首次证明，以单药最大耐受剂量9 mg每日一次持续给予伊那利塞、哌柏西利以及标准剂量和给药方案的来曲唑或氟维司群联合用药，具有可控的安全性特征。主要不良反应包括低级别的口腔炎、高血糖和腹泻，以及低发生率的低级别皮疹（均为1-2级）。尽管存在剂量调整（中断、减少或撤药）的情况，但每种治疗成分的中位累积剂量强度仍然较高。结合本研究中观察到的中位治疗持续时间长以及因不良事件（AE）导致的治疗中断率总体较低，表明这是一个总体耐受性良好的联合治疗方案。此外，药代动力学（PK）数据表明，这些药物之间没有药物间相互作用（DDI），进一步支持以最大化通路抑制的剂量和给药方案给予这一基于伊那利塞的联合靶向治疗方案。 尽管本研究中的队列规模较小，但临床前联合用药疗效数据的可转化性得到了有前景且持久的抗肿瘤活性数据的支持。在来曲唑组，中位PFS为23.3个月；氟维司群组，中位PFS为35.0个月。尽管数据有限，但伊那利塞、哌柏西利和ET的联合用药在配对的肿瘤组织样本中降低了PI3K/AKT通路生物标志物表达和增殖，这既证实了伊那利塞的作用机制，也证实了这一联合用药的抗肿瘤效果。 该研究结果为伊那利塞与CDK4/6抑制剂+ET的联合用药提供了支持性证据，并促成了INAVO120的研究设计。INAVO120是一项正在进行的III期研究，旨在评估伊那利塞、哌柏西利和氟维司群联合用药在PIK3CA突变且HR+/HER2-局部晚期/转移性乳腺癌患者中的疗效，这些患者的疾病在治疗期间或完成辅助内分泌治疗后12个月内进展，且此前未接受过转移性疾病的系统治疗。INAVO120研究在PFS方面显示了显著的统计学且有临床意义的改善，以及可控的安全性和耐受性特征。 研究结论 在该I/Ib期研究中，伊那利塞联合哌柏西利及ET展现出了可控的安全性特征，具有良好的耐受性、药物间相互作用（DDI），以及有前景且持久的初步抗肿瘤活性。这些数据表明，在PIK3CA突变、HR+/HER2-LA/mBC中，靶向ER、CDK4/6和PI3K通路药物的协同作用，并支持III期INAVO120研究进一步评估伊那利塞联合哌柏西利及氟维司群的疗效。 ▌参考文献： Jhaveri, Komal L et al. “Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 42,33 (2024): 3947-3956. doi:10.1200/JCO.24.00110 （来源：《肿瘤瞭望》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。