Zimberelimab

在癌症研究领域，美国癌症研究协会（AACR）年会一直是汇聚前沿成果、推动行业发展的重要平台。今年的 AACR '25 大会即将拉开帷幕，众多药企计划在会上发布关键数据，这些数据有望对癌症治疗格局产生重大影响，尤其是在头颈部癌和肺癌治疗方面，同时也会为 TIGIT、VEGF 等特定药物模式的发展提供新的方向。默沙东 Keytruda 研究数据备受期待今年的 AACR '25 大会上，默沙东（Merck）关于其重磅 PD - 1 抑制剂 Keytruda 的一项关键研究数据备受瞩目。在头颈部鳞状细胞癌（HNSCC）治疗领域，默沙东的 III 期 KEYNOTE - 689 研究成果将在大会上详细公布。2024 年 10 月，默沙东曾公布该研究的初步结果，显示 Keytruda 在无事件生存期方面有 “统计学显著且临床意义重大的改善”，在总生存期方面也呈现 “改善趋势” 。但当时并未披露具体数据，Keytruda 在这一适应症上的疗效程度仍不明确。William Blair 的分析师认为，KEYNOTE - 689 研究结果将对更广泛的 HNSCC 治疗领域产生影响 。分析师马特・菲普斯（Matt Phipps）表示，该研究的详细结果可能会影响该领域的其他参与者，如 Merus 公司及其双特异性抗体 petosemtamab，还有正在推进口服酪氨酸激酶抑制剂 zanzalintinib 的 Exelixis 公司 。勃林格殷格翰肺癌研究成果待揭晓肺癌治疗也是本次大会的重要看点，勃林格殷格翰（Boehringer Ingelheim）的研究备受关注。其开展的 Beamion LUNG - 1 试验，旨在研究 HER2 酪氨酸激酶阻滞剂 zongertinib 在非小细胞肺癌（NSCLC）中的疗效。2024 年 9 月公布的 Ib 期研究结果显示，zongertinib 的客观缓解率达到 66.7%，94% 接受治疗的患者肿瘤缩小 。在本次大会上，勃林格殷格翰将公布 Beamion LUNG - 1 试验的更多结果。多伦多玛格丽特公主癌症中心的高级医学肿瘤学家、AACR 候任主席莉莲・萧（Lillian Siu）认为，该研究结果可能会 “改变临床实践” 。特定药物模式迎来关键节点除了针对特定癌症的研究，一些特定的治疗药物模式也将在本次大会迎来关键节点。以 VEGF - PD (L) 1 双特异性抗体为例，去年 9 月，Summit Therapeutics 和 Akeso 宣布其研究中的双特异性抗体 ivonescimab 在一线治疗 NSCLC 方面优于 Keytruda，引发了肿瘤学界的震动 。本周三，这两家合作方进一步报告，该候选药物在 NSCLC 患者中的无进展生存期比百济神州的 PD - 1 抑制剂 Tevimbra 更优。自去年 9 月以来，涌现出了一批 VEGF 双特异性抗体和部分三特异性抗体，至少有 13 种相关药物，包括 ivonescimab 以及杭州德琪医药开发的 DXA023 - G017 等，将在 AACR 大会上公布数据 。不过，生物技术投资公司 MPM BioImpact 的联合管理合伙人克里斯蒂安娜・巴登（Christiana Bardon）提醒，这些药物大多仍处于临床前阶段，但如果成功，它们有可能颠覆肿瘤治疗格局。TIGIT 领域同样备受关注。近几个月，TIGIT 领域遭遇诸多挫折。上个月，百济神州因后期数据令人失望，不得不放弃其 TIGIT 药物 ociperlimab，该药物在 III 期 AdvanTIG - 302 试验中不太可能达到总生存期的主要终点 。罗氏的抗 TIGIT 抗体 tiragolumab 在 2024 年 11 月的 SKYSCRAPER - 01 研究中也未能显著改善局部晚期不可切除或转移性 NSCLC 患者的总生存期 。罗氏将在 AACR 大会上公布该研究的更多数据，这一全面解读对 TIGIT 抑制剂领域意义重大 。此外，吉利德（Gilead）和 Arcus 合作的抗 TIGIT 抗体 domvanalimab 与 PD - 1 疗法 zimberelimab 联合使用，在特定类型 NSCLC 患者中显著提高了无进展生存期和总生存期 ，他们还在对该联合疗法进行头颈部癌（HSNCC）的试验，并计划在 AACR 大会上展示中期数据。AACR '25 大会即将成为展示癌症研究最新进展的重要舞台，默沙东、勃林格殷格翰等药企的关键数据发布，以及特定药物模式相关研究成果的呈现，将为癌症治疗领域带来新的思路和方向。这些数据能否转化为临床实践中的有效疗法，推动癌症治疗取得新突破，值得持续关注。参考来源：https://www.biospace.com/drug-development/merck-boehringer-ingelheim-more-to-present-key-data-at-aacr-25识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

iStock, LevKPhoto Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF. On Friday, the streets of Chicago, Illinois—or at least, the halls of its McCormick Place Convention Center—will flood with hundreds of cancer experts from across the country. The annual meeting of the American Association for Cancer Research is in town and will host some of the most cutting-edge research in oncology. Expectations are great for this year’s event, which will host a few highly impactful readouts, some of which could have far-reaching implications for the market and for clinical practice. One of the most anticipated presentations is a detailed readout for Merck’s Phase III KEYNOTE-689 study , which evaluated its blockbuster PD-1 blocker Keytruda in head and neck squamous cell carcinoma (HNSCC). In October 2024, the pharma provided a topline peek at the study’s results, noting that Keytruda elicited a “statistically significant and clinically meaningful improvement” in event-free survival and a “trend toward improvement” in overall survival. Merck did not provide specific data at the time, and Keytruda’s magnitude of efficacy in this indication remains unknown. However, in an April 16 note to investors, William Blair analysts said they expect KEYNOTE-689 to have “read-through to the broader” HNSCC treatment space. “Merck’s Keynote-689 will have some impact on the head and neck cancer landscape/market opportunity,” William Blair analyst Matt Phipps added in an email to BioSpace . Detailed findings from the trial will likely affect other players in this space, including Merus and its bispecific antibody petosemtamab, and Exelixis, which is advancing its oral tyrosine kinase inhibitor zanzalintinib, according to Phipps. Aside from HNSCC, AACR 2025 could also witness big readouts in lung cancer. In an email to BioSpace , AACR president-elect Lillian Siu, a senior medical oncologist at the Princess Margaret Cancer Centre in Toronto, pointed to Boehringer Ingelheim’s Beamion LUNG-1 trial, which she said could be “practice-changing.” The trial is studying the HER2 tyrosine kinase blocker zongertinib in non-small cell lung cancer (NSCLC). A Phase Ib readout in September 2024 demonstrated a 66.7% objective response rate for zongertinib, which also shrank tumors in 94% of treated patients. Boehringer Ingelheim is scheduled to release additional findings from Beamion LUNG-1 on Monday . Modality Movement Beyond specific indications, many experts also expect this year’s AACR cycle to be critical for certain treatment modalities. “VEGF-PD(L)1 bispecifics took the oncology world by storm” in September last year, when Summit Therapeutics and Akeso announced that their investigational bispecific antibody ivonescimab bested Keytruda as a frontline NSCLC treatment, Christiana Bardon, co-managing partner at biotech investment firm MPM BioImpact, told BioSpace in an email. The oncology partners doubled down on those results on Wednesday, reporting that the candidate yielded better progression-free survival than BeiGene’s PD-1 inhibitor Tevimbra in patients with NSCLC. “Since [September 2024], a wave of VEGF bispecifics and some trispecifics have emerged,” according to Bardon, who noted that at least 13 of these, including ivonescimab and a candidate developed by Hangzhou DAC Biotechnology and dubbed DXA023-G017 , will have data at AACR. “There’s even a VEGF bispecific with an [antibody-drug conjugate] payload,” she said. Bardon is quick to caution, however, that assets playing in this space “are still mostly at the preclinical stage.” Nevertheless, “they have the potential to disrupt the oncology landscape if successful.” William Blair’s Phipps, for his part, is focused on the TIGIT space, which in recent months has been battered by setbacks. Last month, for instance, BeiGene was forced to scrap its TIGIT asset ociperlimab after disappointing late-stage data, which showed that the candidate was “unlikely to meet the primary endpoint of overall survival” in the Phase III AdvanTIG-302 trial in NSCLC. However, arguably the most high-pro belongs to Roche, which in November 2024 reported that its anti-TIGIT antibody tiragolumab failed the SKYSCRAPER-01 study in locally advanced unresectable or metastatic NSCLC, unable to significantly improve overall survival versus placebo. The pharma did not provide specific data at the time, but will do so at AACR. A more comprehensive readout “will have important implications for the TIGIT inhibitor space,” Phipps said. “We know the trial failed, but are there reasons that can be gleaned that might allow others to still succeed with this target?” Among these other players are partners Gilead and Arcus, which in November 2024 reported Phase III data showing that their anti-TIGIT antibody domvanalimab, when combined with the PD-1 therapy zimberelimab, significantly boosted progression-free and overall survival in patients with a specific type of NSCLC, as compared with zimberelimab or chemotherapy. The partners are also trialing the domvanalimab-zimberelimab combo in HSNCC, for which they are scheduled to present mid-stage data at AACR.