New data evaluating INCB161734 in CRC highlight its clinical activity across KRAS G12D-mutated tumor types and support initiation of a Phase 3 study in second-line CRC planned for 2027<\/i><\/p>\n
INCB161734 and INCA33890 demonstrated manageable safety profiles in combination with standard-of-care (SoC) chemotherapies<\/i><\/p>\n
New collaborations with Bristol Myers Squibb and Synnovation in PDAC to evaluate INCB161734 in combination with navlimetostat, an MTA-cooperative PRMT5 inhibitor, and SNV1521, a PARP1 inhibitor, respectively<\/i><\/p>\n
These results and additional updates will be presented at an analyst and investor event on Monday, October 26, 2026, from 7:30 \u2013 9:00 p.m. CET (2:30 \u2013 4:00 p.m. EDT)<\/i><\/p>\n
WILMINGTON, Del.–(BUSINESS WIRE<\/a>)– \n\u201cAt Incyte we are focused on improving outcomes for people living with cancer. The data presented for INCB161734 and INCA33890 show the potential of both programs to improve the standard-of-care in hard-to-treat diseases,\u201d said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. \u201cAcross pancreatic and colorectal cancers, we continue to see encouraging evidence of clinical activity and manageable safety profiles, supporting the promise of these programs across tumor types and lines of therapy. Together, INCB161734 and INCA33890 are emerging as the foundation of our growing solid tumor portfolio, with the potential to address significant patient needs.\u201d<\/p>\n INCB161734 (KRAS G12D)\u200b in <\/i>Pancreatic Ductal Adenocarcinoma<\/i><\/b><\/p>\n ON\/OFF KRAS Inhibition Shows Deep and Durable Responses Across Combinations, With Manageable Safety \nDeep and durable treatment responses were observed. Specifically:<\/p>\n \nAcross treatment groups, INCB161734 in combination with GEMNabP or mFOLFIRINOX was tolerable and the safety and tolerability profile was broadly consistent with established profiles of SoC regimens. GI TRAEs were mostly Grade 1\/2 and improved during treatment.<\/p>\n \nThe global Phase 3 study (DAWN-303) evaluating INCB161734 in combination with investigator\u2019s choice of both SoC chemotherapies in first-line metastatic PDAC is ongoing with topline data anticipated in 2028. A Phase 3 study in the adjuvant PDAC setting is planned for 2027.<\/p>\n \nAdditionally, two new clinical trial collaborations to evaluate novel combinations with INCB161734 in PDAC are planned:<\/p>\n INCB161734 (KRAS G12D)\u200b in<\/i>Colorectal Cancer<\/i><\/b><\/p>\n Clinical Activity and Manageable Safety as Monotherapy and in Combination in Patients with Advanced\/Metastatic CRC \nSpecifically:<\/p>\n \nThe Phase 3 study (DAWN-302) evaluating INCB161734 plus cetuximab for previously treated metastatic CRC is expected to initiate in the first half of 2027.<\/p>\n \nIn addition to the previously announced collaboration with Genmab<\/a> in CRC, Phase 1 studies and cohorts are ongoing or planned to explore INCB161734\u2019s potential to address resistance mechanisms, including an ongoing study of INCB161734 plus cetuximab and SoC chemotherapy in front-line metastatic CRC and a tumor-agnostic cohort.<\/p>\n INCA33890 (TGF\u03b2R2\u00d7PD-1)\u200b in MSS CRC<\/i><\/b><\/p>\n Notable Clinical Activity Across Treatment Combinations and Key Patient Subgroups, With Manageable Safety \nOf note:<\/p>\n \nThe Phase 3 NEXERA-303 study evaluating INCA33890 plus FOLFOX and bevacizumab as a first-line treatment for patients with MSS CRC is ongoing with topline data expected in 2029. A Phase 2 study in MSS CRC in the adjuvant setting post-chemotherapy is also ongoing.<\/p>\n \nMore information regarding the 2026 ESMO Congress and the data from Incyte\u2019s portfolio being featured at the meeting can be found on the ESMO website: https:\/\/www.esmo.org\/meeting-calendar\/esmo-congress-2026<\/a>.<\/p>\n Analyst Event and Webcast \nThe event will be webcast and can be accessed via the Events and Presentations<\/a> tab of the Investor section of Incyte.com<\/a>; the replay will be available for 30 days.<\/p>\n About INCB161734 \nINCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073<\/a>) study which is currently enrolling patients with previously untreated KRAS G12D-mutated PDAC to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy. Incyte will also be initiating the Phase 3 DAWN-302 study evaluating INCB161734 in combination with cetuximab in patients with previously treated metastatic colorectal cancer.<\/p>\n \nINCB161734 is also being evaluated as a monotherapy and in combination SoC chemotherapy (gemcitabine\/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160<\/a>).<\/p>\n About INCA33890 \nINCA33890 is being evaluated in a Phase 1 study (NCT05836324<\/a>) in patients with advanced or metastatic solid tumors. It is also being evaluated in Phase 2 and Phase 3 studies, including the Phase 2 NEXERA-204 study (NCT07823322<\/a>) assessing INCA33890 monotherapy for the treatment of circulating tumor DNA-positive stage 2\/3 MSS CRC after curative resection and chemotherapy. Additionally, the Phase 3 NEXERA-303 study (NCT07284849<\/a>) evaluating the efficacy and safety of INCA33890 in combination with FOLFOX and bevacizumab for patients with previously untreated metastatic MSS CRC is currently enrolling.<\/p>\n About Incyte \nTo learn more, visit Incyte.com<\/a> or Investor.Incyte.com<\/a>. Follow us on social media: LinkedIn<\/a>, X<\/a> and Instagram<\/a>.<\/p>\n Forward-Looking Statements \nActual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte\u2019s and its partners\u2019 products; the ability of Incyte and its partners\u2019 to achieve commercial success for their marketed products and product candidates, if approved; Incyte\u2019s and its partners\u2019 ability to obtain and maintain protection of intellectual property for their products and technology; Incyte\u2019s reliance on third parties and partners; the acceptance of Incyte\u2019s and its partners\u2019 products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte\u2019s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.<\/p>\n 1<\/sup> INCA33890, a TGF\u03b2R2\u00d7PD-1 bispecific Biclonics antibody, is developed in collaboration with Merus (legacy partnership); Merus is now part of Genmab A\/S.<\/p>\n<\/td>\n<\/tr>\n 2 <\/sup>Deng Z, et al. Signal Transduct Target Ther<\/i>. 2024;9:61.<\/p>\n<\/td>\n<\/tr>\n 3 <\/sup>Mariathasan S, et al. Nature<\/i>. 2018;554:544-548.<\/p>\n<\/td>\n<\/tr>\n 4 <\/sup>Donkor MK, et al. Immunity<\/i>. 2011;35:123-34.<\/p>\n<\/td>\n<\/tr>\n 5 <\/sup>Gulley JL, et al. Mol Oncol<\/i>. 2022;16:2117-2134.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u00a0<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261026987057\/en\/<\/a><\/span><\/p>\n Media
\nIncyte (Nasdaq:INCY) announced new results from its advancing oncology portfolio, including updated results for its KRAS G12D inhibitor (INCB161734) in pancreatic ductal adenocarcinoma (PDAC) and advanced or metastatic colorectal cancer (CRC), and its TGF\u03b2R2\u00d7PD-1 bispecific antibody (INCA338901<\/sup>) in microsatellite stable CRC (MSS CRC). The data were featured in three rapid oral sessions (Abstract #3137RO, Abstract #1007RO and Abstract #1954RO, respectively) at the European Society of Medical Oncology (ESMO) Congress 2026.<\/p>\n
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<\/b>New Phase 1 data (cut-off July 6, 2026; n=54) showed encouraging clinical efficacy and a favorable safety profile for INCB161734 1,200 mg once daily (QD) in combination with standard-of-care (SoC) chemotherapy (gemcitabine\/nab-paclitaxel [GEMNabP] (n=26) or modified FOLFIRINOX [mFOLFIRINOX] (n=27)) in patients with metastatic PDAC harboring a documented KRAS G12D mutation.<\/p>\n\n
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<\/b>New Phase 1 data (cut-off July 6, 2026; n=49) demonstrated antitumor activity and a manageable safety profile for INCB161734 1,200 mg QD as monotherapy and in combination with cetuximab in patients with advanced\/metastatic KRAS G12D-mutated CRC.<\/p>\n\n
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<\/b>In patients with advanced or MSS CRC, new Phase 1 data (cut-off August 26, 2026; n=94) demonstrated encouraging preliminary efficacy across cohorts and within subgroups and a manageable safety profile with INCA33890 900 mg intravenously (IV) every two weeks (Q2W) in combination with SoC therapies (bevacizumab [n=39], FOLFOX plus bevacizumab [n=43], FOLFIRI plus bevacizumab [n=6] or cetuximab [n=6]).<\/p>\n\n
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<\/b>The data from the ESMO oral presentations will be discussed at an in-person analyst and investor event at ESMO on Monday, October 26, 2026, from 7:30 \u2013 9:00 p.m. CET (2:30 \u2013 4:00 p.m. EDT).<\/p>\n
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<\/b>INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON\/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.<\/p>\n
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<\/b>INCA33890 is an investigational, TGF\u03b2R2\u00d7PD-1 bispecific antibody, developed in collaboration with Merus (now part of Genmab) using their Biclonics\u00ae<\/sup> antibody platform, engineered to block TGF-\u03b2\u2013mediated signaling in immune cells co-expressing TGF-\u03b2R2 and PD-1. TGF\u03b2 is known to promote cancer immune evasion and predicts poor response to PD-(L)1 targeted therapies. INCA33890 aims to spare tissues where TGF-\u03b2 signaling is important for normal function, avoiding the known toxicity of a broad blocking of the TGF-\u03b2 pathway. INCA33890 offers a novel, promising, potentially first-in-class targeted treatment strategy for patients with advanced or metastatic solid tumors, including microsatellite stable colorectal cancer (MSS CRC).2,3,4,5<\/sup><\/p>\n
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<\/b>Incyte is redefining what\u2019s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology, and Inflammation and Autoimmunity.<\/p>\n
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<\/b>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the presentation of data from Incyte\u2019s clinical development pipeline, the potential offered by INCB161734 and INCA33890, expectations regarding planned or ongoing clinical trials for each, including the timing for enrollment, initiation and data read outs, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world, and Incyte\u2019s aspirations and goals as set forth under the heading \u201cAbout Incyte.\u201d<\/p>\n\n
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