在刚刚结束的第61届美国临床肿瘤学会（ASCO）年会上，罗氏公布了多项肿瘤领域的最新研究进展，重点展示了乳腺癌领域、肺癌领域和血液肿瘤领域的肿瘤产品组合新数据。这些关键研究结果，进一步突显了罗氏致力于为癌症患者开发变革性疗法的承诺。

III期INAVO120研究显示，在内分泌耐药、PIK3CA突变HR+/HER2-局部晚期或转移性乳腺癌患者一线治疗中，伊那利塞（inavolisib）联合哌柏西利+氟维司群治疗组的中位OS长达34个月，较安慰剂联合对照组的27个月显著延长7个月。

● 与哌柏西利（palbociclib）和氟维司群（fulvestrant）相比，基于Itovebi™ (inavolisib)的治疗方案将内分泌耐药、PIK3CA突变的HR阳性、HER2阴性晚期乳腺癌患者的死亡风险降低了30%以上^[1]

● 最新数据在2025年美国临床肿瘤学会（ASCO）年会的口头报告环节呈报，同期并发表于《新英格兰医学杂志》^[1]

PIK3CA突变存在于约40%的HR阳性晚期乳腺癌中，且与不良预后相关^[2,3]。除INAVO120研究外，Itovebi目前还在三项公司申办的III期研究（INAVO121, INAVO122，INAVO123）中进行评估，这些研究均针对PIK3CA突变的局部晚期或转移性乳腺癌，采用不同的联合治疗方案。^[4-7]

罗氏正在乳腺癌和其他肿瘤类型中展开更多探索，希望能将这种靶向治疗的益处带给更多携带PIK3CA突变的患者。

III期IMforte研究取得积极结果：Tecentriq联合Lurbinectedin治疗广泛期小细胞肺癌显示显著生存获益

● 在该侵袭性强、生存期有限且治疗选择稀缺的癌症类型中，疾病进展或死亡风险降低46%，死亡风险降低27%^[8]

● 首个在广泛期小细胞肺癌（ES-SCLC）一线维持治疗中，证实无进展生存期和总生存期均取得临床意义改善的III期研究^[9,10]

● 研究数据已在2025年ASCO年会口头报告环节公布，并同步发表于《柳叶刀》^[8,11]

III期STARGLO研究随访两年的更新数据证实：Glofit-GemOx方案可延长复发或难治性弥漫性大B细胞淋巴瘤患者的总生存期

● 对于不适合移植的复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者，总生存期持续显示出具有临床意义的改善，中位OS尚未达到，疾病死亡风险降低40%^[12]

● 更新的Landmark分析数据显示，在Glofit-GemOx方案治疗结束时获得完全缓解的患者中，82%未发生疾病进展^[12]

● 同时，完全缓解率达58.5%，且患者可持续获得完全缓解状态，目前随访两年数据显示DoCR仍未达到^[12]

所以，对于这种侵袭性、危及生命的疾病，在复发或初始治疗失败后及时启动有效治疗至关重要！Glofit-GemOx方案作为一种亟需的、固定疗程、“即用型”TCE疗法具有巨大潜力。

“我们将集中端到端的资源，聚焦乳腺癌、肺癌和恶性血液肿瘤——这些存在大量未被满足临床需求的疾病领域，而我们在这方面已积淀深厚专业优势。在三大重点疾病领域之外，我们还将持续探索其他具有变革性治疗潜力的癌症类型，寻求突破性的创新。”

 

参考文献：

[1] Turner NC, et al. INAVO120 Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2025 May 30-June 03; Chicago, USA. Abstract #1003.
[2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22(1):1002.
[3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.

[4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from:  https://classic.clinicaltrials.gov/ct2/show/NCT04191499.
[5] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862.
 [6] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239.
 [7] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 May]. Available from: https://clinicaltrials.gov/study/NCT06790693.
[8] Paz-Ares L, et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. Presented at: ASCO Annual Meeting; 2025 May 30-Jun 03; Chicago, IL, USA. Abstract #8006.
[9] Belluomini L, et al. Maintenance or consolidation therapy in small-cell lung cancer: an updated systematic review and meta-analysis. Seminars in Oncology. 2022; 49(5): 389-393. 
[10] Roviello G, et al. No advantage in survival with targeted therapies as maintenance in patients with limited and extensive-stage small cell lung cancer: a literature-based meta-analysis of randomized trials. Clin Lung Cancer. 2016; 17(5): 334–340.
[11] Paz-Ares L, et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 02. [Internet; cited June 2025]. Available from: https://doi.org/10.1016/S0140-6736(25)01011-6.

[12] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. Presented at: ASCO Annual Meeting; 2025 May 30 - Jun 3. Abstract #7015.

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