ASCO 2021：摘要概览与展望12：阿斯利康全新数据支持通过更早治疗和改变患者体验来彻底改变癌症结局的雄心壮志
2021-05-28 JACKZHAO MedSci原创
Lynparza是第一种在辅助条件下对种系BRCA突变的高危HER2阴性早期乳腺癌患者显示临床益处的靶向药物
美国临床肿瘤学会（ASCO）年度会议将在2021年6月4日至8日举行，国内外诸多顶级研究成果即将公布。在大会揭幕之前，已有科学人员开始宣布临床研究摘要以及报告的计划。梅斯医学将持续关注并报道学术亮点，分享给各位同道。
近期系列乳腺癌专题汇总：
ASCO 2021：摘要概览与展望11 |乳腺癌最新研究概览（浸润性乳腺癌专栏）
ASCO 2021：摘要概览与展望10 |乳腺癌最新研究概览（三阴性乳腺癌专栏）
ASCO 2021 :摘要概览与展望8 | 乳腺癌最新研究概览（男性乳腺癌专栏）
Lynparza是第一种在辅助条件下对种系BRCA突变的高危HER2阴性早期乳腺癌患者显示临床益处的靶向药物
相对于依鲁替尼，先前治疗的患者在一线慢性淋巴细胞白血病中表现出持续的四年临床获益，并且房颤率降低
Imfinzi的五年数据代表了不可切除的III期肺癌的III期免疫治疗试验中报告的最长生存时间
2021年6月4日至8日举行的美国临床肿瘤学会（ASCO）年会上阿斯利康将呈现新的数据，强调其重新定义癌症治疗的雄心。在公司行业领先的肿瘤学产品组合中，将有100多个摘要包含21种已批准的和潜在的新药，其中有4篇摘要被选为最新论文，12篇口服报告和一份全会报告。
肿瘤学业务部执行副总裁Dave Fredrickson表示：“我们今年在ASCO的数据表明，我们坚定不移地决心彻底改变癌症治疗并加强我们在肺癌，乳腺癌以及血液学领域的领先优势。 Lynparza和Imfinzi的新结果继续验证了我们具有治愈意图的早期癌症治疗策略，而Calquence的数据则表明了我们致力于通过证明安全，可耐受的药物来改善患者体验的承诺。”
肿瘤学研究与发展高级副总裁克里斯蒂安·马萨塞西（Cristian Massacesi）表示：“在过去几年中，患有BRCA突变的乳腺癌患者的前景发生了根本变化，ASCO的OlympiA数据将代表向前迈出的又一关键步骤。我们有机会从根本上改变患有高危早期疾病的女性的预后，并在辅助环境中引入潜在的新护理标准。此外，三阴性乳腺癌的有希望的数据将挑战当前的治疗预期，并为这种侵略性疾病的新方法带来希望。”
通过更早治疗癌症来重新定义生存
完整的OlympiA III期早期乳腺癌试验结果的演讲将重点介绍Lynparza（奥拉帕尼）与安慰剂相比，在生殖系BRCA突变（gBRCAm）高危患者的辅助治疗中对疾病复发风险的影响表皮生长因子受体2（HER2）阴性的早期乳腺癌。 Lynparza是第一种在早期乳腺癌中显示出作为辅助治疗的临床益处的PARP抑制剂。 2021年2月，该试验的独立数据监测委员会建议，应根据计划中的中期分析转向早期早期分析，该中期分析显示出在无创生存期的主要终点中具有可持续且临床相关的治疗效果。
PACIFIC III期试验的五年总体生存数据将继续支持Imfinzi（durvalumab）对于无法切除的III期非小细胞肺癌（NSCLC）并发化学放疗后仍未进展的患者具有前所未有的持续生存优势治疗。这些数据代表了在这种治疗环境中进行的免疫疗法的III期试验中报告的最长存活时间。
此外，由德国乳腺癌组织进行的外部赞助的GeparNuevo试验的II期数据的口头陈述将显示，Imfinzi在标准的新辅助化疗中加入后，具有改善早期三阴性乳腺癌（TNBC）患者预后的潜在潜力。
改变患者的体验
ELEVATE-TN试验的四年随访数据将证实Calquence单药治疗或Calquence与obinutuzumab联合治疗具有持续的临床益处，为未接受过治疗的慢性淋巴细胞性白血病（CLL）的成年人提供定制治疗的灵活性。
此外，相比于依鲁替尼，以前接受过CLL治疗且有较高进展风险的成年人，ELEVETE-RR III期临床试验的详细结果的口服演示将证明房颤，心律事件明显减少，而Calquence（acalabrutinib）的停药更少。 ELEVATE-RR是首次在CLL中使用两种Bruton酪氨酸激酶抑制剂进行的头对头III期临床试验，证实了Calquence对CLL患者有利的风险。
DESTINY-Gastric01和DESTINY-CRC01的最新数据将进一步支持Enhertu（曲妥珠单抗德鲁替康）在可靶向HER2的癌症中的潜在作用。此外，在DESTINY-Breast01试验中，对先前治疗过的具有脑转移的HER2阳性乳腺癌患者进行亚组分析的数据将加强对了解Enhertu在难以治疗的患者人群中潜在获益的承诺。
初步结果将与BEGONIA Ib / II期试验（包括Enhertu）在转移性TNBC中的Imfinzi组合的试验共享。此外，将与ceralasertib，共济失调性毛细血管扩张和rad3相关（ATR）激酶抑制剂的II期试验共享数据，并与Imfinzi联合使用，表明该组合在先前抗PD1的黑色素瘤患者中显示出有希望的抗肿瘤活性治疗失败了。
其他证据将强调需要改善中枢神经系统的控制，以及诸如Tagrisso（osimertinib）等新一代酪氨酸激酶抑制剂（TKI）在晚期Epi的治疗中的作用。
推进行业领先的临床开发计划
总体而言，阿斯利康将在2021 ASCO上分享18份壁报，描述正在进行中的试验，这些试验正在探索跨多种类型和不同阶段的癌症的新型药物及其组合。
这些海报包括：
Datopotamab deruxtecan（Dato-DXd）-TROPION-Lung01 III期试验对已接受转移NSCLC治疗的患者进行了datopotamab deruxtecan的治疗，以及BEGONIA试验IMFINZIin与datopotamab deruxtecan在转移性TNBC中的联合用药
ENHERTU-单独或以多种组合测试ENHERTU的试验，包括：DESTINY-Breast07，DESTINY-PanTumor01和DESTINY-CRC02
IMFINZI-在可切除的胃和胃食管连接癌中进行新辅助-辅助IMFINZI和化学疗法的MATTERHORN III期试验，以及BEGONIA I / II期I / II试验以新型组合对IMFINZI进行一线治疗TNBC患者，包括ENHERTU和datopotamab德鲁克特坎。
CALQUENCE-CALQUENCE的ESCALADE III期临床试验与标准化疗联合用于65岁及以下，新诊断为弥漫性大B细胞淋巴瘤（最常见的非霍奇金淋巴瘤类型）的患者
Camizestrant（AZD9833）-SERENA-4 III期临床试验，比较了具有雌激素受体阳性，HER2阴性晚期乳腺癌的下一代口服选择性雌激素受体降解剂（SERD）加palbociclib与阿那曲唑加palbociclib的比较。以前未接受过晚期疾病全身治疗的人
Adavosertib-WEE1抑制剂adavosertib的ADAGIO II期多中心试验，用于治疗复发性或持续性子宫浆液性癌（一种高度侵袭性子宫内膜癌）
科学界的合作对于改善患者的治疗效果至关重要。 LYNPARZA与Merck＆Co.，Inc.合作开发和商业化。阿斯利康与Daiichi Sankyo Company，Limited（Daiichi Sankyo）合作，在全球范围内开发和商业化ENHERTU和datopotamab deruxtecan。
2021 ASCO 阿斯利康重点摘要（英文）1
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Lead author |
Abstract title |
Presentation details2 |
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Immuno-Oncology |
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Spigel, D |
Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial. |
Abstract #8511 Poster Discussion Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers June 4, 2021 |
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Janjigian, Y |
MATTERHORN: Efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer—A randomized, double-blind, placebo-controlled, phase 3 study. |
Abstract #TPS4151 Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary June 4, 2021 |
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McCoon, P |
T-cell receptor pharmacodynamics associated with survival and response to tremelimumab (T) in combination with durvalumab (D) in patients (pts) with unresectable hepatocellular carcinoma (uHCC). |
Abstract #4087 Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary June 4, 2021 |
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Schmid, P |
BEGONIA: Phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC)—Initial results from arm 1, d+paclitaxel (P), and arm 6, d+trastuzumab deruxtecan (T-DXd). |
Abstract #1023 Poster Discussion Session Breast Cancer—Metastatic June 4, 2021 |
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Schmid, P |
BEGONIA: Phase 1b/2, open-label, platform study of the safety and efficacy of durvalumab (D) ± paclitaxel (P) with novel oncology therapies for first line metastatic triple-negative breast cancer (mTNBC): Addition of Arm 7, D + datopotamab deruxtecan (Dato-DXd; DS-1062). |
Abstract #TPS1105 Poster Session Breast Cancer—Metastatic June 4, 2021 |
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Kwon, M |
Phase II study of ceralasertib (AZD6738), in combination with durvalumab in patients with metastatic melanoma who have failed prior anti-PD-1 therapy. |
Abstract #9514 Poster Discussion Session Melanoma/Skin Cancers June 4, 2021 |
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Suárez, C |
Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer. |
Abstract #4511 Poster Discussion Session Genitourinary Cancer—Kidney and Bladder June 4, 2021 |
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Tumor drivers and resistance |
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Janzic, U |
Real-world outcomes and clinical characteristics of patients with brain metastases from EGFR mutated non-small cell lung cancer: Data from a large retrospective study (REFLECT). |
Abstract #9086 Poster Session Lung Cancer—Non-Small Cell Metastatic June 4, 2021 |
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Im, S-A |
SERENA-4: A phase 3 comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease. |
Abstract #TPS1101 Poster Session Breast Cancer—Metastatic June 4, 2021 |
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Tada, H |
Adjuvant gefitinib versus cisplatin/vinorelbine in Japanese patients with completely resected, EGFR-mutated, stage II-III non-small cell lung cancer (IMPACT, WJOG6410L): A randomized phase 3 trial. |
Abstract #8501 Oral Abstract Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers June 6, 2021 |
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Antibody drug conjugates |
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Yoh, K |
A randomized, phase 3 study of datopotamab deruxtecan (Dato-DXd; DS-1062) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (TROPION-Lung01). |
Abstract #TPS9127 Poster Session Lung Cancer – Non-small Cell Metastatic June 4, 2021 |
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Andre, F |
Trastuzumab deruxtecan (T-DXd) combinations in patients with HER2-positive advanced or metastatic breast cancer: A phase 1b/2, open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast07). |
Abstract #TPS1096 Poster Session Breast Cancer—Metastatic June 4, 2021 |
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Li, BT |
A phase 2, multicenter, open-label study evaluating trastuzumab deruxtecan (T-DXd) for the treatment of solid tumors harboring specific HER2-activating mutations (DESTINY-PanTumor01). |
Abstract #TPS3162 Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology June 4, 2021 |
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Yoshino, T |
Trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing metastatic colorectal cancer (mCRC): Final results from a phase 2, multicenter, open-label study (DESTINY-CRC01). |
Abstract #3505 Oral Abstract Session Gastrointestinal Cancer—Colorectal and Anal June 7, 2021 |
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Raghav, K |
Trastuzumab deruxtecan in patients with HER2-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC): A randomized, multicenter, phase 2 study (DESTINY-CRC02). |
Abstract #TPS3620 Poster Session Gastrointestinal Cancer—Colorectal and Anal June 4, 2021 |
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Jerusalem, G |
Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: a subgroup analysis of the DESTINY-Breast01 trial. |
Abstract #526 Poster Session Breast Cancer— Local/Regional/Adjuvant June 4, 2021 |
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Yamaguchi, K |
Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: Final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01). |
Abstract #4048 Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary June 4, 2021 |
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DNA damage response |
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Tutt, A |
OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high risk HER2-negative early breast cancer. |
Abstract #LBA1 Plenary Session June 6, 2021, 1:00pm EDT |
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Liu, JF |
ADAGIO: A phase IIb, open-label, single-arm, multicenter study assessing the efficacy and safety of adavosertib (AZD1775) as treatment for recurrent or persistent uterine serous carcinoma. |
Abstract #TPS5612 Poster Session Gynecologic Cancer June 4, 2021 |
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Poveda, A |
Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase IIIb OPINION primary analysis. |
Abstract #5545 Poster Session Gynecologic Cancer June 4, 2021 |
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Matthews, CA |
Olaparib treatment (Tx) in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Overall survival (OS) results from the phase II LIGHT study. |
Abstract #5515 Poster Discussion Session Gynecologic Cancer June 4, 2021 |
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Pautier, P |
Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial. |
Abstract #5514 Poster Discussion Session Gynecologic Cancer June 4, 2021 |
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Hematology |
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Byrd, J |
First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia. |
Abstract #7500 Oral Abstract Session Hematologic Malignancies June 7, 2021 |
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Sharman, JP |
Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Elevate-TN four-year follow up. |
Abstract #7509 Poster Discussion Session Hematologic Malignancies June 4, 2021 |
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Sehn, L |
ESCALADE: A phase 3 study of acalabrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for patients ≤65y with untreated non-germinal center B-cell–like (non-GCB) diffuse large B-cell lymphoma (DLBCL). |
Abstract #TPS7572 Poster Session Hematologic Malignancies June 4, 2021 |
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174 company-sponsored or supported abstracts will be presented at ASCO 2021. |
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2Beginning Friday,June 4, 2021 09:00 EDT oral presentations, poster discussions and poster sessions will be available on demand for 180 days including video and slide presentations and discussant commentary. |
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在此留言
#ASC#
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#早治疗#
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#患者体验#
34
#癌症结局#
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学习了，谢谢分享
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