{"id":22213,"date":"2023-04-14T14:42:39","date_gmt":"2023-04-14T09:12:39","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=22213"},"modified":"2023-06-14T11:05:54","modified_gmt":"2023-06-14T05:35:54","slug":"aacr-2023-preview-and-top-data-readouts","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/aacr-2023-preview-and-top-data-readouts","title":{"rendered":"American Association for Cancer Research (AACR) 2023 Preview – Top Data Readouts"},"content":{"rendered":"\n

The upcoming AACR 2023 Annual Meeting will have a range of abstracts, including regular abstracts, clinical trials, and late-breaking abstracts. Among the abstracts being presented at the conference, we have listed a few potential abstracts, which we have listed in the below table. The table includes information about ongoing clinical trials for cancer drugs and devices, which various pharma companies are conducting in the high and mid stages of development. The agenda of this preview includes a quick glance at the top company-sponsored abstracts expected to present their much-awaited data readouts, while a few of them are all set to present their prospective trial designs.<\/p>\n\n\n\n

    \n
  1. Data presentation by Key pharma players such as Roche<\/strong> in Hepatocellular Carcinoma, AstraZeneca<\/strong> and Daiichi<\/strong> in NSCLC, Merck<\/strong> in Biliary Tract Carcinoma, Chimerix<\/strong> in H3K27 mutant Glioma, Pfizer<\/strong> on BRAFV600 mutant melanoma<\/a><\/strong> and others players are highlighted in the below table:<\/li>\n<\/ol>\n\n\n\n
    S.No<\/strong><\/td>Drug\/Device<\/strong><\/td>Company<\/strong><\/td>Title<\/strong><\/td>Patient segment<\/strong><\/td>Abstract<\/strong><\/td><\/tr>
    1<\/strong><\/td>Atezolizumab + bevacizumab<\/td>Roche<\/td>IMbrave050: Phase III study of adjuvant atezolizumab + bevacizumab versus active surveillance in patients with hepatocellular carcinoma (HCC)<\/a><\/strong> at high risk of disease recurrence following resection or ablation<\/td>HCC at High Risk of Recurrence After Surgical Resection or Ablation (Adjuvant)<\/td>CT003<\/td><\/tr>
    2<\/strong><\/td>Durvalumab + platinum-based chemotherapy<\/td>AstraZeneca<\/td>AEGEAN: Phase III trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC<\/td>Stages II and III NSCLC (Neoadjuvant\/Adjuvant)<\/td>CT005<\/td><\/tr>
    3<\/strong><\/td>Pembrolizumab + gemcitabine + cisplatin<\/td>Merck & Co<\/td>KEYNOTE-966: Pembrolizumab in combination with gemcitabine and cisplatin for advanced biliary tract cancer a Phase III study<\/td>Advanced and\/or Unresectable Biliary Tract Carcinoma (1L)<\/td>CT008<\/td><\/tr>
    4<\/strong><\/td>Dordaviprone (ONC201)<\/td>Chimerix<\/td>ACTION: Phase III study of dordaviprone (ONC201) in patients with newly diagnosed H3 K27M-mutant diffuse glioma<\/td>H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy (1L)<\/td>CT060<\/td><\/tr>
    5<\/strong><\/td>Optune + Radiation therapy + Temozolomide (*Optune is a device)<\/td>NovoCure<\/td>TRIDENT: Phase III study (EF-32): First-line Tumor Treating Fields (TTFields; 200 kHz) therapy concomitant with chemo-radiation, followed by maintenance TTFields\/temozolomide in newly diagnosed glioblastoma<\/td>Glioblastoma (1L)<\/td>CT061<\/td><\/tr>
    6<\/strong><\/td>Gedatolisib + fulvestrant \u00b1 palbociclib<\/td>Celcuity<\/td>VIKTORIA-1: Phase III study of gedatolisib + fulvestrant  \u00b1 palbociclib in patients with HR+\/ HER2- advanced breast cancer<\/a><\/strong> previously treated with a CDK4\/6 inhibitor plus a non-steroidal aromatase inhibitor<\/td>Patients With HR+\/HER2- Advanced Breast Cancer  (2L)<\/td>CT063<\/td><\/tr>
    7<\/strong><\/td>GLSI-100<\/td>Greenwich LifeSciences<\/td>Flamingo-01: Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy<\/td>HER2\/Neu +  Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy<\/td>CT064<\/td><\/tr>
    8<\/strong><\/td>Patritumab deruxtecan<\/td>Daiichi Sankyo<\/td>HERTHENA-Lung02: A randomized Phase III study of patritumab deruxtecan vs platinum-based chemotherapy in locally advanced or metastatic EGFR-mutated NSCLC<\/a> after progression with a third generation EGFR tyrosine 
    kinase inhibitor<\/td>    		Metastatic or Locally Advanced EGFRm NSCLC after failure of EGFR Tyrosine Kinase Inhibitor therapy (2L+)<\/td>CT066<\/td><\/tr>
    9<\/strong><\/td>Encorafenib + binimetinib + pembrolizumab<\/td>Pfizer<\/td>STARBOARD: Phase III study evaluating encorafenib + binimetinib + pembrolizumab (pembro) for first-line treatment of unresectable locally advanced or metastatic BRAF V600-mutant melanoma<\/td>Unresectable Locally Advanced or Metastatic BRAF V600-mutant Melanoma (1L)<\/td>CT069<\/td><\/tr><\/tbody><\/table>
    Phase III Abstracts presenting at AACR 2023<\/strong><\/figcaption><\/figure>\n\n\n\n
      \n
    1. Drawing attention to the Phase II data readout, we have cancer vaccine players Moderna<\/strong> and Transgene <\/strong>excited about their personalized therapy. Merck <\/strong>is readily evaluating its flagship product as a combination in high-grade serous ovarian carcinoma, Aadi Biosciences<\/strong> heading towards grabbing a tumor agnostic label in TSC1 or TSC2 mutation. We also await for Pieris<\/strong> and Hutchmed\u2019s <\/strong>data in Gastric cancer, along with Affimed\u2019s <\/strong>shift in focus by <\/strong>launching a combination of AFM13 <\/strong>with allogeneic NK cells in peripheral T-cell lymphoma<\/a><\/strong>.<\/li>\n<\/ol>\n\n\n\n
      S.No<\/strong><\/td>Drug<\/strong><\/td>Company<\/strong><\/td>Title<\/strong><\/td>Patient segment<\/strong><\/td>Abstract<\/strong><\/td><\/tr>
      1<\/strong><\/td>mRNA-4157 + pembrolizumab<\/td>Moderna\/Merck & Co<\/td>Keynote-942 : A personalized cancer vaccine, mRNA-4157, combined with pembrolizumab versus pembrolizumab in patients with resected high-risk melanoma: Efficacy and safety results from open-label Phase II mRNA-4157-P201<\/td>High-Risk Melanoma (adjuvant)<\/td>CT001<\/td><\/tr>
      2<\/strong><\/td>AFM13<\/td>Affimed<\/td>REDIRECT: A Phase II study of AFM13 in patients with CD30-positive relapsed or refractory PTCL<\/a><\/strong><\/td>Relapsed or Refractory CD30-positive PTCL (2L)<\/td>CT024<\/td><\/tr>
      3<\/strong><\/td>TG4001 + avelumab<\/td>Transgene<\/td>Phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent\/metastatic (R\/M) HPV-16 positive anogenital cancers<\/a><\/strong><\/td>Patients With HPV-16 Positive Recurrent or Metastatic Malignancies (2L)<\/td>CT045<\/td><\/tr>
      4<\/strong><\/td>Pembrolizumab + Standard of Care (SOC) \u00b1 MK-4830<\/td>Merck  & Co<\/td>MK-4830-002: Phase II study of pembrolizumab + chemotherapy \u00b1 MK-4830 as neoadjuvant treatment for high-grade serous ovarian cancer<\/td>Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer<\/td>CT046<\/td><\/tr>
      5<\/strong><\/td>JDQ443<\/td>Novartis Pharmaceuticals<\/td>A Phase II trial of JDQ443 in KRAS G12C-mutated NSCLC<\/strong><\/a> with PD L1 expression <1% or PD-L1 expression\u22651% and an STK11 co-mutation<\/td>Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression < 1% or a PD-L1 Expression \u2265 1% and an STK11 Co-mutation (1L)<\/td>CT048<\/td><\/tr>
      6<\/strong><\/td>Nab-sirolimus<\/td>Aadi Bioscience<\/td>PRECISION I: Phase II, multicenter open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2<\/td>Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes<\/td>CT057<\/td><\/tr>
      7<\/strong><\/td>Savolitinib<\/td>Hutchmed<\/td>Phase II study of savolitinib in patients with METamplified gastroesophogeal junctio (GE) n adenocarcinomas or gastric cancer<\/td>Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients With MET Gene Amplifications (2L)<\/td>CT152<\/td><\/tr>
      8<\/strong><\/td>Cinrebafusp alfa + ramucirumab + paclitaxel<\/td>Pieris Pharmaceuticals<\/td>Combination of cinrebafusp alfa with ramucirumab and paclitaxel is well tolerated and elicits encouraging clinical activity in patients with HER2-positive gastric<\/a><\/strong> \/GEJ adenocarcinoma in Phase II<\/td>HER2+ Gastric or GEJ Adenocarcinoma (3L)<\/td>CT154<\/td><\/tr>
      9<\/strong><\/td>Tisotumab vedotin<\/td>Seagen<\/td>innovaTV 207: Tisotumab vedotin in squamous cell carcinoma of head and neck (SCCHN): interim analysis from Phase II<\/td>Squamous cell carcinoma of head and neck <\/td>CT164<\/td><\/tr>
      10<\/strong><\/td>Telisotuzumab vedotin<\/td>AbbVie<\/td>LUMINOSITY: Preliminary efficacy of telisotuzumab vedotin treatment in the 2L\/3L setting in MET gene amplified (MET Amp), c-Met protein overexpressing (c-Met OE), non-squamous NSCLC<\/a><\/strong><\/td>c-Met+ Non-Small Cell Lung Cancer (2L\/3L)<\/td>CT214<\/td><\/tr><\/tbody><\/table>
      Phase II Abstracts Presenting at AACR 2023<\/strong><\/figcaption><\/figure>\n\n\n\n
        \n
      1. Post Amgen\u2019s Lumakras<\/strong> and Mirati\u2019s Krazati\u2019s<\/strong> approval in targeting KRAS mutations<\/a><\/strong>, we have a huge list of contenders ready to enter the most lucrative KRASG12C space, including Eli Lilly, Genentech, and Genfleet, whereas MapKure, Kinnate and BeiGene <\/strong>focus on targeting the RAF pathway.<\/li>\n<\/ol>\n\n\n\n
        S.No<\/strong><\/td>Drug<\/strong><\/td>Company<\/strong><\/td>Title<\/strong><\/td>Patient segment<\/strong><\/td>Abstract<\/strong><\/td><\/tr>
        1<\/strong><\/td>LY3537982<\/td>Eli Lilly and Company<\/td>A first-in-human Phase I study of LY3537982, a highly selective and potent KRAS G12C inhibitor in patients with KRAS G12Cmutant advanced solid tumors<\/td>KRAS G12C-Mutant Advanced Solid Tumors<\/td>CT028<\/td><\/tr>
        2<\/strong><\/td>GDC-6036 + cetuximab<\/td>Genentech\/Roche<\/td>Phase Ib study of GDC-6036 in combination with cetuximab in patients with colorectal cancer (CRC) with KRAS G12C mutation<\/td>Colorectal cancer with KRAS G12C mutation<\/td>CT029<\/td><\/tr>
        3<\/strong><\/td>IBI351 (GFH925)<\/td>Genfleet Therapeutics<\/td>Phase I study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors: Updated results of the phase I study<\/td>Advanced Solid Tumors With KRAS G12C Mutations<\/td>CT030<\/td><\/tr>
        4<\/strong><\/td>BGB-3245<\/td>MapKure<\/td>A first-in-human, Phase Ia\/Ib, open-label, dose-escalation and expansion study to investigate the safety, pharmacokinetics, and antitumor activity of the RAF dimer inhibitor BGB-3245 in patients with advanced or refractory tumors<\/td>Advanced or Refractory Tumors<\/td>CT031<\/td><\/tr>
        5<\/strong><\/td>Exarafenib (KIN-2787)<\/td>Kinnate Biopharma<\/td>Trials in progress: a global Phase I\/Ib clinical trial evaluating exarafenib (KIN-2787), a highly selective pan-RAF inhibitor, in adult patients with BRAF-altered solid tumors and NRAS mutant melanoma<\/td>BRAF\/NRAS-mutated advanced or Metastatic Solid tumors<\/td>CT032<\/td><\/tr>
        6<\/strong><\/td>BGB-283 (lifirafenib) + PD-0325901 (mirdametinib)<\/td>BeiGene\/SpringWorks Therapeutics<\/td>Safety, pharmacokinetics, and antitumor activity findings from a Phase Ib, open-label, dose-escalation and expansion study investigating RAF dimer inhibitor lifirafenib in combination with MEK inhibitor mirdametinib in patients with advanced or refractory solid tumors<\/td>Patients With Advanced or Refractory Solid Tumors<\/td>CT033<\/td><\/tr><\/tbody><\/table>
        KRAS Pathway Abstracts Presenting at AACR 2023<\/strong><\/figcaption><\/figure>\n\n\n\n

        <\/p>\n\n\n\n

        S.No<\/strong><\/td>Drug<\/strong><\/td>Company<\/strong><\/td>Title<\/strong><\/td>Patient segment<\/strong><\/td>Abstract<\/strong><\/td><\/tr>
        1<\/strong><\/td>Sacituzumab govitecan + zimberelimab + etrumadenant<\/td>Gilead Sciences<\/td>VELOCITY-Lung: A phase II study evaluating safety and efficacy of sacituzumab govitecan + zimberelimab  + etrumadenant in patients with advanced or metastatic non-small cell lung cancer (mNSCLC) progressing on or after platinum (PT)- based chemotherapy and checkpoint inhibitors (CPI)<\/td>Advanced or mNSCLC (1L)<\/td>CT049<\/td><\/tr>
        2<\/strong><\/td>Imvotamab + ZYNLONTA (loncastuximab tesirine)<\/td>IGM Biosciences<\/td>A phase I\/II randomized study of imvotamab monotherapy and in combination with loncastuximab tesirine in relapsed\/refractory non-Hodgkin lymphomas<\/td>Relapsed or Refractory B Cell NHL (3L+)<\/td>CT052<\/td><\/tr>
        3<\/strong><\/td>Datopotamab deruxtecan \u00b1  Anticancer Agents<\/td>AstraZeneca\/Daiichi Sankyo<\/td>TROPION-PanTumor03: Phase II, multicenter study of datopotamab deruxtecan (Dato-DXd) as monotherapy and in combination with anticancer agents in patients  with advanced\/metastatic solid tumors<\/td>Advanced or Metastatic Solid Tumours<\/td>CT058<\/td><\/tr>
        4<\/strong><\/td>Pembrolizumab \u00b1 sacituzumab govitecan<\/td>Merck & Co\/Gilead Sciences<\/td>Pembrolizumab with and without sacituzumab govitecan as first line treatment for metastatic non-small-cell lung cancer (NSCLC) with PD-L1 TPS \u226550%: phase III KEYNOTE-D46\/EVOKE-03 study<\/td>Participants With PD L1 TPS Greater Than or Equal to \u226550% mNSCLC (1L)<\/td>CT067<\/td><\/tr>
        5<\/strong><\/td>AL102<\/td>Ayala Pharmaceuticals<\/td>Double-blind placebo-controlled trial of AL102 for treatment of progressing desmoid tumors<\/a><\/strong>: the RINGSIDE phase III study design<\/td>Patients With Progressing Desmoid Tumors (1L+ , 2L+)<\/td>CT070<\/td><\/tr><\/tbody><\/table>
        Trial Design Abstracts Presenting in AACR 2023<\/strong><\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"

        The upcoming AACR 2023 Annual Meeting will have a range of abstracts, including regular abstracts, clinical trials, and late-breaking abstracts. Among the abstracts being presented at the conference, we have listed a few potential abstracts, which we have listed in the below table. The table includes information about ongoing clinical trials for cancer drugs and […]<\/p>\n","protected":false},"author":6,"featured_media":22232,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":5,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[3057,20585,20588,20587,18919,20584,20046],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-22213","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-aacr","tag-aacr-2023","tag-aacr-2023-annual-meeting","tag-aacr-conference","tag-healthcare-conference","tag-healthcare-conference-2023","tag-healthcare-events","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"\nAACR 2023 | Preview and Top Data Readouts | Key Insights<\/title>\n<meta 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