Zimberelimab

Arcus’s highest priority is to execute on its ongoing Phase 3 trial and overall development plan aimed at establishing casdatifan as the standard-of-care and backbone therapy for clear cell renal cell carcinoma (ccRCC), including the initiation of a Phase 3 trial in the first-line (1L) setting At least three data presentations are planned for casdatifan in 2026, including updated data from the four late-line monotherapy cohorts of the Phase 1/1b ARC-20 study, which will be presented at a medical conference in February 2026 Arcus’s first development candidate for inflammatory and autoimmune diseases, an oral MRGPRX2 antagonist for chronic spontaneous urticaria, is expected to enter the clinic in 2026 With approximately $1 billion of cash and investmentsi, Arcus expects to be able to fund its planned operations until at least the second half of 2028 Arcus will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases, today outlined its 2026 priorities for casdatifan and its emerging inflammation and immunology (I&I) programs. “As we enter 2026, the highest priorities for Arcus will be the rapid enrollment of PEAK-1, our Phase 3 study evaluating casdatifan in immunotherapy (IO)-experienced ccRCC patients, and the initiation of a 1L Phase 3 study evaluating casdatifan informed by data from multiple ongoing and soon-to-be initiated Phase 1 combination studies,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “This year, we also expect to advance our first small molecule for inflammatory disease into the clinic.” Casdatifan (HIF-2a inhibitor for ccRCC) Upcoming Data Presentations: Arcus expects to have at least three data readouts for casdatifan, its potential best-in-class HIF-2a inhibitor, during 2026: In February 2026, Arcus plans to present updated data from the four cohorts of the Phase 1/1b ARC-20 study evaluating casdatifan monotherapy in late-line ccRCC at a medical conference. These data will include updated progression-free survival (PFS) data for the 100mg once-daily (QD) cohort of casdatifan and for all four monotherapy cohorts combined (n=121), as well as updated biomarker data correlating erythropoietin suppression with clinical outcomes. Mid-year, Arcus expects to present updated data for approximately 45 patients treated in ARC-20 with casdatifan plus cabozantinib in IO-experienced ccRCC; this cohort evaluates the same combination in the same setting as PEAK-1, an ongoing Phase 3 study, which represents Arcus’s “fast-to-market” strategy in ccRCC. In the second half of the year, Arcus expects to present data from multiple ARC-20 cohorts evaluating casdatifan in early-line metastatic settings, including data from the cohort evaluating casdatifan plus the anti-PD-1 antibody, zimberelimab, in 1L ccRCC. This will be the first presentation of data for a tyrosine kinase inhibitor (TKI)-sparing HIF-2a inhibitor-based regimen in the 1L setting. Data from this cohort are expected to show an acceptable safety profile and early efficacy, including a low rate of primary progression, which is essential in this setting. The cohort is designed to de-risk Arcus’s strategy to displace TKIs as an early-line treatment. This will be the first presentation of data for a tyrosine kinase inhibitor (TKI)-sparing HIF-2a inhibitor-based regimen in the 1L setting. Data from this cohort are expected to show an acceptable safety profile and early efficacy, including a low rate of primary progression, which is essential in this setting. The cohort is designed to de-risk Arcus’s strategy to displace TKIs as an early-line treatment. Development Strategy: Arcus’s development plan is designed to establish casdatifan as a foundational standard of care across multiple settings of ccRCC, which represents a potential global market opportunity of $5 billion or more. Arcus’s ongoing Phase 3 study for casdatifan in IO-experienced ccRCC, PEAK-1, is evaluating casdatifan plus cabozantinib, the most widely used TKI in this setting. Similar Phase 3 trials in this setting have completed enrollment in 18 months or less, and Arcus’s goal is to achieve a similar timeline. Arcus’s strategy in 1L ccRCC is focused on TKI-free regimens, which are enabled by the consistently low rate of primary progression observed with casdatifan across all cohorts and settings evaluated to date. This strategy has the potential to bring about a highly desirable paradigm shift with a first-in-class regimen that delays treatment with TKIs and their associated toxicities to later lines of therapy. The following cohorts are designed to efficiently determine the optimal 1L registrational strategy for casdatifan: Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody): This combination is currently being evaluated in ARC-20, and this cohort has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026. Casdatifan plus anti-PD-1-containing regimens: Arcus is planning to initiate new cohorts to evaluate two other TKI-free casdatifan plus anti-PD-1-containing regimens in the 1L setting. Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca). Data from these cohorts will inform and enable the initiation of a Phase 3 study for a casdatifan-containing, TKI-free regimen in the 1L setting. Arcus is targeting initiation of this study by year-end 2026. Small-Molecule Inflammation & Immunology Programs Arcus’s I&I strategy leverages the company’s demonstrated capabilities in small-molecule drug discovery, focusing on indications currently dominated by blockbuster injectable biologics and on highly validated targets. Arcus’s I&I portfolio currently includes several oral small molecules, including an MRGPRX2 antagonist and inhibitors of TNF, CCR6 and CD40L. The company is also developing an anti-CD89 antibody that has potential in patients with a type of rheumatoid arthritis that is currently difficult to treat. Arcus expects to advance its lead inflammation program, a potential best-in-class oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, into clinical development in 2026. The molecule was designed to have exquisite potency, enabling substantially lower-dose target coverage relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities. Arcus also expects to advance an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease (such as ulcerative colitis), into the clinic in late 2026 or early 2027. Quemliclustat (CD73 inhibitor for pancreatic cancer) Arcus's oncology portfolio also includes quemliclustat, a small-molecule CD73 inhibitor, which is being evaluated in PRISM-1, a registrational Phase 3 study in 1L pancreatic cancer that completed enrollment in September 2025. Results from this study are expected in the first half of 2027. Runway Guidance Arcus has approximately $1 billion of cash and investmentsi and expects to be able to fund its planned operations until at least the second half of 2028. This guidance includes a rapid wind down of the Phase 3 STAR-221 and Phase 2 EDGE-GASTRIC studies. In the first quarter of 2026, Arcus and Gilead expect to conduct an analysis of STAR-121, a Phase 3 study evaluating domvanalimab plus zimberelimab and chemotherapy in 1L non-small cell lung cancer. Depending on the outcome of this analysis, Arcus could realize additional cost savings. Presentation at 44th Annual J.P. Morgan Healthcare Conference Arcus will present at the 44th Annual J.P. Morgan Healthcare Conference at 3:00 pm PT on Wednesday, January 14, 2026. A live webcast of the presentation will be available on the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event. Domvanalimab, zimberelimab and quemliclustat are investigational molecules, and neither Arcus nor Gilead has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan is also an investigational molecule, and Arcus has not received approval from any regulatory authority for any use globally, and its safety and efficacy have not been established. About RCC According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of HIF-2a, a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments. About Zimberelimab Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types. Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com. Forward Looking Statement This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Arcus’s goals and strategy for its casdatifan and inflammation and immunology programs; the potential for casdatifan to become a standard‑of‑care or “backbone” therapy or to be best‑in‑class; planned, expected or potential timing, occurrence and content of clinical data readouts, presentations and publications (including those from ARC‑20, eVOLVE‑RCC02, PEAK‑1 and PRISM‑1); the design, initiation, enrollment, conduct and timelines of ongoing or planned clinical trials (including the potential initiation of a 1L Phase 3 study by year‑end 2026 and enrollment goals for PEAK‑1); the anticipated clinical profile of Arcus’s product candidates, including safety, tolerability and activity, and expectations regarding TKI‑sparing regimens; the advancement and therapeutic potential of Arcus’s I&I candidates (including MRGPRX2 antagonist and TNF inhibitor) and the timing of their entry into the clinic; the scope and timing of program wind‑downs; market opportunity estimates; collaboration activities and expectations (including with AstraZeneca and Gilead); and Arcus’s cash runway and other financial or operational expectations. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the outcomes of anticipated analyses from ongoing Phase 3 studies with domvanalimab, including STAR-121 and PACIFIC-8; delays in the wind-down of STAR-221 and EDGE-Gastric; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products, including casdatifan; risks associated with preliminary and interim data not being guarantees that future data will be similar; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; further changes to Arcus’s strategy and operating plans; changes in the competitive landscape for Arcus’s programs; reliance on collaborators and third parties (including AstraZeneca and Gilead) and related dependencies; regulatory feedback that may alter design or timing; and assumptions underlying cash‑runway guidance and program wind‑downs and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law. i Based on cash, cash equivalents and marketable securities balance of $841 million as of September 30, 2025, and net proceeds of approximately $270 million from Arcus’s November 2025 financing. Investor Inquiries: Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri AD, Corporate Communications (510) 406-8520 mbassiri@arcusbio.com

编者按：2025年，癌症治疗领域持续迎来多项积极进展。新批准的药物不仅显著提高了患者的生存率，而且为整个生物医药界带来进一步的创新。其中，多款新型小分子疗法获得美国FDA批准，而靶向蛋白降解剂、抗体偶联药物（ADC）与双特异性抗体仍是产业持续关注的焦点。作为创新的赋能者、客户信赖的合作伙伴以及全球健康产业的贡献者，药明康德将持续通过独特的“CRDMO”业务模式，助力更多合作伙伴，为全球病患带来突破性创新疗法。本文将根据近期《自然》子刊Nature Cancer所发布的观点文章并结合公开讯息，回顾在2025年癌症治疗领域的药物研发与产业进展。小分子领域持续向前在靶向蛋白降解剂领域，Jazz Pharmaceuticals开发的“first-in-class”药物Modeyso（dordaviprone）于2025年8月获FDA加速批准上市，用于治疗1岁及以上、携带H3 K27M突变且在既往治疗后疾病进展的弥漫性中线胶质瘤成人和儿童患者。同月，美国FDA受理了Arvinas与辉瑞（Pfizer）递交的vepdegestrant新药申请，拟用于治疗既往接受内分泌治疗的、雌激素受体阳性（ER+）、HER2阴性（HER2-）且伴有ESR1突变的晚期或转移性乳腺癌患者。新闻稿指出，vepdegestrant是首个在乳腺癌患者中显示临床获益的PROTAC®疗法，若获批，将成为首个美国FDA批准的PROTAC®雌激素受体降解剂。9月，礼来（Eli Lilly and Company）口服选择性雌激素受体降解剂（SERD）Inluriyo（imlunestrant）获批用于治疗ER+/HER2-且伴有ESR1突变的晚期或转移性乳腺癌患者。罗氏（Roche）也于12月宣布，其口服新一代SERD疗法giredestrant在ER+/HER2-早期乳腺癌患者的3期试验达到主要终点，显著降低侵袭性疾病复发或死亡风险达30%。FDA在2025年还批准了多款口服酪氨酸激酶抑制剂（TKI），包括拜耳（Bayer）的Hyrnuo（sevabertinib）、勃林格殷格翰（Boehringer Ingelheim）的Hernexeos（zongertinib）、迪哲医药的Zegfrovy（sunvozertinib）、Nuvation Bio的Ibtrozi（taletrectinib），均用于治疗非小细胞肺癌（NSCLC）患者。此外，Kura Oncology与Kyowa Kirin联合开发的口服menin抑制剂Komzifti（ziftomenib），以及Deciphera Pharmaceuticals与Ono Pharmaceutical联合开发的CSF1R抑制剂Romvimza（vimseltinib），也分别获批用于治疗携带NPM1突变的复发/难治性急性髓系白血病（AML）和腱鞘巨细胞瘤（TGCT）患者。与此同时，美国FDA于2025年5月加速批准Verastem Oncology开发的RAF/MEK抑制剂avutometinib联合FAK抑制剂defactinib组成的治疗方案Avmapki Fakzynja Co-pack，用于治疗复发性低级别浆液性卵巢癌（LGSOC）成年患者，这些患者曾接受系统性治疗且肿瘤携带KRAS突变。这一组合属于少见的“两个新药”同时获批的案例，而不仅仅是包含已上市药物的组合方案。此外，FDA还批准了Medexus Pharmaceuticals旗下Grafapex（treosulfan）作为烷化剂，与氟达拉滨（fludarabine）联合使用，作为1岁及以上AML或骨髓增生异常综合征（MDS）患者接受同种异体造血干细胞移植（alloHSCT）前的预处理方案。抗体偶联药物继续发力2025年，FDA共批准两款新的抗体偶联药物。其中，由阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）联合开发的Trop2靶向ADC疗法Datroway（datopotamab deruxtecan）于1月获批，用于治疗经治激素受体阳性（HR+）、HER2-乳腺癌患者，并在6月再获加速批准，用于治疗携带EGFR突变的NSCLC患者。与此同时，艾伯维（AbbVie）旗下c-Met靶向ADC疗法Emrelis（telisotuzumab vedotin，teliso-V）也于2025年5月获得FDA加速批准，用于治疗具有高c-Met蛋白过度表达的局部晚期或转移性经治非鳞状NSCLC成年患者。值得一提的是，GSK旗下B细胞成熟抗原（BCMA）靶向ADC于10月重新获批，可与硼替佐米和地塞米松（BVd）联合使用，用于治疗至少接受过两种既往疗法的复发或难治性多发性骨髓瘤（RRMM）成年患者。此外，Genmab在去年4月通过收购普方生物（ProfoundBio）获得的潜在“best-in-class”叶酸受体α（FRα）靶向ADC疗法rinatabart sesutecan（Rina-S），也在2025年8月获FDA授予突破性疗法认定（BTD），用于治疗在含铂化疗方案及PD-1/PD-（L）1治疗后仍复发或进展的子宫内膜癌（EC）成年患者。目前，该疗法用于EC的3期研究正在推进中。除已上市产品外，多家致力于新一代ADC技术平台的创新企业也获得了大额融资，推动赛道持续升温。这些新平台多聚焦于提升药物稳定性、精准靶向能力，或开发创新药物载荷。例如，Callio Therapeutics致力于开发可同时携带两种不同载荷的双载荷ADC，以进一步增强治疗效力，公司于3月成立并获得1.87亿美元融资。而专注于创新载荷开发的Adcytherix则在10月融资1.05亿欧元。同月，Tubulis完成C轮融资第二次增资，使该轮融资总额达到3.44亿欧元。Tubulis的主打候选药物TUB-040是一款靶向NaPi2b抗原的IgG1抗体，通过其专有P5偶联技术与拓扑异构酶I抑制剂exatecan连接，形成带有可切割连接子的ADC疗法，旨在治疗NaPi2b高表达的卵巢癌和肺腺癌。临床1/2a期研究中期数据显示，所有剂量组的总体确认疾病控制率（DCR）达91%。双特异性抗体与抗体疗法进展2025年，PD-1/VEGF双特异性抗体领域进展显著。其中，Akeso与Summit Therapeutics联合开发的ivonescimab受到广泛关注。在一项全球3期研究中，相较单纯化疗，ivonescimab联合化疗在携带EGFR突变的NSCLC患者中显示出改善总生存期（OS）的趋势。此外，其联合化疗用于治疗无法切除或转移性结直肠癌（CRC）患者的全球3期试验也已于10月启动。在产业合作方面，辉瑞（Pfizer）与三生制药（3SBio）于5月签署全球独家许可协议，总金额高达12.5亿美元，用于开发、生产和商业化PD-1/VEGF双特异性抗体SSGJ-707。6月，BioNTech与百时美施贵宝（Bristol Myers Squibb）达成15亿美元合作，共同开发PD-L1/VEGF-A靶向双特异性抗体pumitamig。在12月公布的全球2期试验中，在39例可评估患者中，pumitamig联合化疗治疗局部晚期或转移性三阴性乳腺癌（TNBC）患者的确认客观缓解率（ORR）达到61.5%，未确认ORR为71.8%，DCR为92.3%。目前，已有超过十个VEGF与PD-1/PD-L1联合靶向疗法进入临床阶段。除该领域外，其他双特异性抗体也取得重要进展。7月，美国FDA加速批准再生元（Regeneron Pharmaceuticals）旗下Lynozyfic（linvoseltamab）用于治疗RRMM成人患者。9月底，Genmab宣布以80亿美元收购Merus，其核心资产为处于后期开发阶段的EGFR/LGR5靶向双特异性抗体petosemtamab，已进入两项头颈癌3期临床试验，覆盖一线及二/三线治疗场景，预计其中一至两项试验将在2026年获得中期结果。由于LGR5在多种癌症中表达上调，已成为ADC与T细胞衔接器的重要靶点。同时，武田（Takeda）与信达生物（Innovent Biologics）于10月达成合作，协议中也包括一款靶向PD-1及免疫调节蛋白亚基IL-2α的双特异性融合蛋白。另一方面，阿斯利康（AstraZeneca）旗下PD-1/TIGIT靶向双特异性抗体rilvegostomig用于治疗NSCLC的3期试验正在推进中。Rilvegostomig与ADC疗法Datroway联合用于治疗晚期或转移性尿路上皮癌患者的2期试验显示积极结果，在不适合顺铂的一线患者中，ORR达到68.2%，DCR达95.5%，相关2/3期研究已启动。除双特异性抗体外，其他抗体疗法也迎来新进展。美国FDA与欧洲药品管理局（EMA）分别于9月与11月批准了默沙东（MSD）旗下Keytruda（pembrolizumab）的皮下注射制剂。由康方生物与正大天晴联合开发的抗PD-1单抗Anniko（penpulimab）也在4月获批用于治疗鼻咽癌。同时，吉利德科学（Gilead Sciences）与Arcus Biosciences联合评估Fc失活型抗TIGIT抗体domvanalimab联合抗PD-1单抗zimberelimab及化疗用于胃癌等患者一线治疗的2期研究也传来积极结果，接受该联合疗法患者的中位总生存期达26.7个月。细胞治疗走向体内生成CAR-T细胞模式在细胞治疗领域，行业关注逐步转向体内生成CAR-T细胞疗法。这一模式不仅生产流程更为简化、成本更低，同时有望实现更精准、更高效的细胞改造。吉利德科学旗下Kite公司于2025年8月达成协议，以高达3.5亿美元收购Interius BioTherapeutics。该公司平台可在患者体内直接生成CAR-T细胞，仅需一次静脉输注即可完成治疗，无需预处理化疗或复杂细胞操作，其主打疗法INT2104目前已进入1期试验阶段。与此同时，由诺贝尔奖得主Jennifer Doudna博士共同创立的Azalea Therapeutics于11月正式走出隐匿模式，并完成总计8200万美元的种子轮及A轮融资，用于推进其自主研发的包膜递送载体（EDV）技术平台。该平台已成功在体内将编码CAR的转基因导入T细胞，实现无需细胞体外扩增与预处理的持续抗肿瘤治疗效果。放射性配体疗法稳步推进2025年放射性配体疗法（RLT）的临床推进与投融资活动依然活跃。诺华（Novartis）旗下β粒子治疗药物Pluvicto（lutetium Lu 177 vipivotide tetraxetan）再获FDA批准，用于治疗PSMA阳性转移性去势抵抗性前列腺癌患者。在α粒子药物领域，赛诺菲（Sanofi）于10月宣布，其在研RLT药物AlphaMedix（212Pb-DOTAMTATE）治疗不可切除或转移性、生长抑素受体（SSTR）阳性胃肠胰神经内分泌肿瘤（GEP-NET）患者的2期试验达到全部主要疗效终点，并显著提升总缓解率。图片来源：123RF纵观刚刚过去的全年，可以看到无论是小分子、ADC、双特异性抗体，还是细胞治疗与放射性配体疗法，创新的浪潮正在更快地从实验室走向临床。随着不同疗法模式的兴起，以及产业与学术界的通力合作，相信在2026年会有更多好消息传出，推动癌症治疗的进步，造福更多癌症患者。展望未来，药明康德将继续秉持“让天下没有难做的药，难治的病”的愿景，依托全球研发基地与生产网络，以独特的一体化、端到端的CRDMO模式，提供高效、灵活的解决方案，持续赋能全球合作伙伴释放创新潜能，加速将科学突破转化成为新药、好药。Major Milestones in Cancer Treatment Revealed for 2025In 2025, the field of cancer therapy continued to deliver encouraging advances. Newly approved therapies have not only significantly improved patient survival, but have also driven further innovation across the global biopharmaceutical industry. A major spotlight in 2025 fell on next-generation small-molecule medicines, several of which received U.S. FDA approval, while targeted protein degraders, antibody–drug conjugates (ADCs) and bispecific antibodies remained at the center of attention. As an enabler of innovation, a trusted partner, and a contributor to the global pharmaceutical and life sciences industry, WuXi AppTec will continue to support its partners through its unique CRDMO business model, helping deliver breakthrough treatments to patients worldwide. Drawing upon the latest feature article published inNature Canceralongside publicly available information, this article reviews key R&D and industry developments in cancer therapy in 2025.Continued Progress in Small-Molecule InnovationIn targeted protein degradation, Jazz Pharmaceuticals’ first-in-class therapy Modeyso (dordaviprone) received accelerated approval from FDA in August for adults and children aged one year and older with H3 K27M-mutant diffuse midline glioma whose disease progressed following prior therapy.That same month, the FDA accepted the New Drug Application submitted by Arvinas and Pfizer for vepdegestrant to treat estrogen receptor-positive (ER+)/HER2-negative (HER2-) advanced or metastatic breast cancer withESR1mutation following prior endocrine therapy. According to company statements, vepdegestrant is the first PROTAC® therapy to demonstrate clinical benefit in breast cancer patients and, if approved, would become the first FDA-approved PROTAC® estrogen receptor degrader.In September, Eli Lilly’s oral selective estrogen receptor degrader (SERD) Inluriyo (imlunestrant) was approved for ER+/HER2- advanced or metastatic breast cancer withESR1mutation. Roche also announced in December thatits next-generation oral SERD giredestrant met the primary endpoint in a Phase 3 trial in ER+/HER2- early-stage breast cancer, reducing the risk of invasive disease recurrence or death by 30%.This year, the FDA also approved several oral tyrosine kinase inhibitors (TKIs) fornon-small cell lung cancer (NSCLC), including Hyrnuo (sevabertinib) from Bayer, Hernexeos (zongertinib) from Boehringer Ingelheim, Zegfrovy (sunvozertinib) from Dizal [Jiangsu] Pharmaceutical, and Ibtrozi (taletrectinib) from Nuvation Bio. In addition, the oral menin inhibitor Komzifti (ziftomenib), co-developed by Kura Oncology and Kyowa Kirin, was approved for relapsed or refractory acute myeloid leukemia (AML) withNPM1mutation, while the CSF1R inhibitor Romvimza (vimseltinib), co-developed by Deciphera Pharmaceuticals and Ono Pharmaceutical, was approved for tenosynovial giant cell tumor (TGCT).Also in May, the FDA granted accelerated approval to the combination regimen Avmapki Fakzynja Co-pack, which consists of the RAF/MEK inhibitor avutometinib and FAK inhibitor defactinib from Verastem Oncology, for adults with recurrent low-grade serous ovarian cancer (LGSOC) harboringKRASmutation who previously received systemic therapy. This represents a rare case where two new molecular entities were approved together as a combination treatment.In addition, the FDA approved Grafapex (treosulfan) from Medexus Pharmaceuticals as an alkylating agent to be used with fludarabine as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adults and children aged one year and older with AML or myelodysplastic syndromes (MDS).Antibody–Drug Conjugates Continue to AdvanceIn 2025, the FDA approved two new ADCs.Datroway (datopotamab deruxtecan), a Trop2-targeting ADC co-developed by AstraZeneca and Daiichi Sankyo, was approved in January for the treatment of previously treated hormone receptor-positive (HR+)/HER2- breast cancer, and subsequently received accelerated approval in June for patients withEGFR-mutated NSCLC. Meanwhile, AbbVie’s c-Met-targeting ADC Emrelis (telisotuzumab vedotin, teliso-V) received accelerated FDA approval in May for adults with locally advanced or metastatic, previously treated non-squamous NSCLC whose tumors overexpress c-Met.Notably, GSK’s B-cell maturation antigen (BCMA)-targeting ADC was re-approved in October for use in combination with bortezomib and dexamethasone (BVd) to treat adults with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least two prior lines of therapy. In addition, the potential “best-in-class” folate receptor-α (FRα)-targeting ADC rinatabart sesutecan (Rina-S) — acquired by Genmab via its April 2024 purchase of ProfoundBio — was granted FDA Breakthrough Therapy Designation (BTD) in August 2025 for adults with endometrial cancer (EC) whose disease recurred or progressed following platinum-based chemotherapy and PD-(L)1 therapy. A Phase 3 trial in EC is currently underway.Investment momentum also strengthened across next-generation ADC technology platforms aimed at improving stability, precision targeting, and payload innovation.Callio Therapeutics, which is developing dual-payload ADCs designed to further enhance anti-tumor activity, was founded in March and raised US$187 million. Adcytherix, focused on novel payload innovation, secured €105 million in October. That same month, Tubulis completed a second extension of its Series C round, bringing total proceeds to €344 million.Tubulis’ lead candidate, TUB-040, is an IgG1 antibody targeting the NaPi2b antigen and conjugated via the company’s proprietary P5 platform to the topoisomerase-I inhibitor exatecan through a cleavable linker. It is being developed for NaPi2b-high ovarian and lung adenocarcinoma. Interim Phase 1/2a data showed a confirmed disease control rate (DCR) of 91% across all dose cohorts.Progress in Bispecific Antibodies and Antibody-Based TherapiesSignificant momentum was also seen in the field of PD-1/VEGF bispecific antibodies.Ivonescimab, jointly developed by Akeso and Summit Therapeutics, drew substantial industry attention in 2025. In a global Phase 3 trial, ivonescimab plus chemotherapy demonstrated a trend toward improved overall survival (OS) versus chemotherapy alone inEGFR-mutated NSCLC. A global Phase 3 trial of ivonescimab plus chemotherapy in unresectable or metastatic colorectal cancer (CRC) was also initiated in October.On the partnership front, Pfizer and 3SBio signed a global exclusive licensing agreement in May worth up to US$1.25 billion to develop, manufacture, and commercialize the PD-1/VEGF bispecific antibody SSGJ-707. In June, BioNTech and Bristol Myers Squibb entered into a US$1.5 billion collaboration to co-develop the PD-L1/VEGF-A bispecific antibody pumitamig. In a global Phase 2 study reported in December, among 39 evaluable patients with locally advanced or metastatic triple-negative breast cancer (TNBC), pumitamig plus chemotherapy achieved a confirmed objective response rate (ORR) of 61.5%, an unconfirmed ORR of 71.8%, and a DCR of 92.3%.Today, more than ten VEGF + PD-1/PD-L1-targeting bispecific programs are in clinical development.Progress extended beyond this class as well. In July, the U.S. FDA granted accelerated approval to Regeneron Pharmaceuticals’ bispecific antibody Lynozyfic (linvoseltamab) for adults with R/R multiple myeloma (MM). In late September, Genmab announced the US$8 billion acquisition of Merus, whose lead late-stage bispecific antibody petosemtamab targets EGFR and LGR5. The therapy is currently being evaluated in two Phase 3 head-and-neck cancer trials across first-line and later-line settings, with interim data expected in 2026.Given its upregulated expression across several tumor types, LGR5 has emerged as an increasingly important target for ADCs and T-cell engagers.In addition, Takeda and Innovent Biologics entered into a collaboration in October that includes a PD-1/IL-2α bispecific fusion protein candidate. AstraZeneca’s PD-1/TIGIT bispecific antibody rilvegostomig is also advancing in a Phase 3 trial for NSCLC. In a Phase 2 study evaluating rilvegostomig in combination with the ADC Datroway in advanced or metastatic urothelial carcinoma, the regimen achieved an ORR of 68.2% and a DCR of 95.5% in cisplatin-ineligible first-line patients. Related Phase 2/3 trials are now underway.Beyond bispecifics, other antibody-based therapies also saw progress. The U.S. FDA and European Medicines Agency (EMA) approved the subcutaneous formulation of Keytruda (pembrolizumab) in September and November, respectively. The anti-PD-1 antibody Anniko (penpulimab), co-developed by Akeso and Chia Tai Tianqing Pharmaceutical, was approved in April for nasopharyngeal carcinoma. Meanwhile, Gilead Sciences and Arcus Biosciences reported positive Phase 2 data showing that domvanalimab — an Fc-silent anti-TIGIT antibody — plus the anti-PD-1 antibody zimberelimab and chemotherapy achieved a median OS of 26.7 months as first-line therapy in gastric and related cancers.Cell Therapy Advances Toward In-Vivo CAR-T GenerationIn the cell therapy field, industry attention is increasingly shifting toward in-vivo CAR-T cell generation, an approach that simplifies manufacturing, reduces cost, and may enable more precise and durable cell reprogramming. In August, Kite, a Gilead Sciences company, entered into an agreement to acquire Interius BioTherapeutics for up to US$350 million. Interius’ platform enables direct in-vivo generation of CAR-T cells via a single intravenous infusion, eliminating the need for chemotherapy preconditioning or ex-vivo cell handling. Its lead asset, INT2104, is currently in Phase 1 testing.Meanwhile, Azalea Therapeutics — co-founded by Nobel laureate Dr. Jennifer Doudna — emerged from stealth in November and announced a combined US$82 million seed and Series A financing to advance its proprietary Enveloped Delivery Vehicle (EDV) platform. The technology has demonstrated successful delivery of CAR-encoding transgenes into T cells in-vivo, achieving durable anti-tumor responses without the need for cell expansion or preconditioning.Radiopharmaceutical Therapies Progress SteadilyClinical development and investment activity in radioligand therapy (RLT) continued at a steady pace in 2025.Novartis’ β-emitting therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) received an additional FDA approval for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). In the α-emitter space, Sanofi announced in October that its RLT candidate AlphaMedix (212Pb-DOTAMTATE) met all primary efficacy endpoints in a Phase 2 study in patients with unresectable or metastatic somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), delivering a meaningful improvement in overall response rate.Looking across the year, innovation is clearly moving from bench to bedside at a steady pace, spanning small molecules, ADCs, bispecific antibodies, cell therapies, and radiopharmaceuticals. As new therapeutic modalities emerge and industry–academia collaboration deepens, we look ahead to 2026 with optimism that more breakthroughs will follow, bringing hope and better treatment options to patients worldwide.At WuXi AppTec, we remain committed to advancing transformative therapies for global patients. Together with our partners, we work toward a shared vision that “every drug can be made and every disease can be treated.”参考资料：[1] Senior M. Cancer drug approvals and setbacks in 2025. Nat Cancer. 2025 Dec;6(12):1902-1904. doi: 10.1038/s43018-025-01080-4. PMID: 41372474.[2] Genmab Announces New Data Demonstrating Investigational Rinatabart Sesutecan (Rina-S®) Achieved Anti-Tumor Activity in Heavily Pretreated Patients with Advanced Endometrial Cancer. Retrieved December 28, 2025 from https://www.globenewswire.com/news-release/2025/10/18/3168951/0/en/Genmab-Announces-New-Data-Demonstrating-Investigational-Rinatabart-Sesutecan-Rina-S-Achieved-Anti-Tumor-Activity-in-Heavily-Pretreated-Patients-with-Advanced-Endometrial-Cancer.html[3] Longer-Term Follow-Up of Western Patients Showed Improving, Favorable Trend in Overall Survival in Global Phase III HARMONi Clinical Trial for Ivonescimab Plus Chemotherapy in 2L+ EGFRm NSCLC. Retrieved December 28, 2025 from https://www.businesswire.com/news/home/20250907860109/en/Longer-Term-Follow-Up-of-Western-Patients-Showed-Improving-Favorable-Trend-in-Overall-Survival-in-Global-Phase-III-HARMONi-Clinical-Trial-for-Ivonescimab-Plus-Chemotherapy-in-2L-EGFRm-NSCLC[4] Summit Therapeutics Announces Expansion of Ivonescimab Global Phase III Development Program with HARMONi-GI3 Study in 1L Colorectal Cancer. Retrieved December 28, 2025 from https://www.businesswire.com/news/home/20251017270897/en/Summit-Therapeutics-Announces-Expansion-of-Ivonescimab-Global-Phase-III-Development-Program-with-HARMONi-GI3-Study-in-1L-Colorectal-Cancer[5] BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer. Retrieved December 9, 2025 from https://news.bms.com/news/details/2025/BioNTech-and-Bristol-Myers-Squibb-Present-First-Global-Phase-2-Data-for-PD-L1xVEGF-A-Bispecific-Antibody-Pumitamig-Showing-Encouraging-Efficacy-in-Advanced-Triple-Negative-Breast-Cancer/default.aspx[6] Innovent Biologics Announces Global Strategic Partnership with Takeda to Bring Innovent's Next Gen IO Backbone Therapy and ADC Molecules to the Global Market. Retrieved December 28, 2025 from https://www.prnewswire.com/news-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market-302590770.html[7] Azalea Therapeutics Presents New Preclinical Data Demonstrating Robust In Vivo Generation of TRAC-CAR T Cells Using Enveloped Delivery Vehicles (EDVs). Retrieved December 28, 2025 from https://www.globenewswire.com/news-release/2025/11/20/3192000/0/en/Azalea-Therapeutics-Presents-New-Preclinical-Data-Demonstrating-Robust-In-Vivo-Generation-of-TRAC-CAR-T-Cells-Using-Enveloped-Delivery-Vehicles-EDVs.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。