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American Association for Cancer Research (AACR) 2023 Preview – Top Data Readouts

Apr 14, 2023

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.

Data presentation by Key pharma players such as Roche in Hepatocellular Carcinoma, AstraZeneca and Daiichi in NSCLC, Merck in Biliary Tract Carcinoma, Chimerix in H3K27 mutant Glioma, Pfizer on BRAFV600 mutant melanoma and others players are highlighted in the below table:

S.No	Drug/Device	Company	Title	Patient segment	Abstract
1	Atezolizumab + bevacizumab	Roche	IMbrave050: Phase III study of adjuvant atezolizumab + bevacizumab versus active surveillance in patients with hepatocellular carcinoma (HCC) at high risk of disease recurrence following resection or ablation	HCC at High Risk of Recurrence After Surgical Resection or Ablation (Adjuvant)	CT003
2	Durvalumab + platinum-based chemotherapy	AstraZeneca	AEGEAN: Phase III trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC	Stages II and III NSCLC (Neoadjuvant/Adjuvant)	CT005
3	Pembrolizumab + gemcitabine + cisplatin	Merck & Co	KEYNOTE-966: Pembrolizumab in combination with gemcitabine and cisplatin for advanced biliary tract cancer a Phase III study	Advanced and/or Unresectable Biliary Tract Carcinoma (1L)	CT008
4	Dordaviprone (ONC201)	Chimerix	ACTION: Phase III study of dordaviprone (ONC201) in patients with newly diagnosed H3 K27M-mutant diffuse glioma	H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy (1L)	CT060
5	Optune + Radiation therapy + Temozolomide (*Optune is a device)	NovoCure	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	Glioblastoma (1L)	CT061
6	Gedatolisib + fulvestrant ± palbociclib	Celcuity	VIKTORIA-1: Phase III study of gedatolisib + fulvestrant ± palbociclib in patients with HR+/ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a non-steroidal aromatase inhibitor	Patients With HR+/HER2- Advanced Breast Cancer (2L)	CT063
7	GLSI-100	Greenwich LifeSciences	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	HER2/Neu + Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy	CT064
8	Patritumab deruxtecan	Daiichi Sankyo	HERTHENA-Lung02: A randomized Phase III study of patritumab deruxtecan vs platinum-based chemotherapy in locally advanced or metastatic EGFR-mutated NSCLC after progression with a third generation EGFR tyrosine kinase inhibitor	Metastatic or Locally Advanced EGFRm NSCLC after failure of EGFR Tyrosine Kinase Inhibitor therapy (2L+)	CT066
9	Encorafenib + binimetinib + pembrolizumab	Pfizer	STARBOARD: Phase III study evaluating encorafenib + binimetinib + pembrolizumab (pembro) for first-line treatment of unresectable locally advanced or metastatic BRAF V600-mutant melanoma	Unresectable Locally Advanced or Metastatic BRAF V600-mutant Melanoma (1L)	CT069

Phase III Abstracts presenting at AACR 2023

Drawing attention to the Phase II data readout, we have cancer vaccine players Moderna and Transgene excited about their personalized therapy. Merck is readily evaluating its flagship product as a combination in high-grade serous ovarian carcinoma, Aadi Biosciences heading towards grabbing a tumor agnostic label in TSC1 or TSC2 mutation. We also await for Pieris and Hutchmed’s data in Gastric cancer, along with Affimed’s shift in focus by launching a combination of AFM13 with allogeneic NK cells in peripheral T-cell lymphoma.

S.No	Drug	Company	Title	Patient segment	Abstract
1	mRNA-4157 + pembrolizumab	Moderna/Merck & Co	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	High-Risk Melanoma (adjuvant)	CT001
2	AFM13	Affimed	REDIRECT: A Phase II study of AFM13 in patients with CD30-positive relapsed or refractory PTCL	Relapsed or Refractory CD30-positive PTCL (2L)	CT024
3	TG4001 + avelumab	Transgene	Phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent/metastatic (R/M) HPV-16 positive anogenital cancers	Patients With HPV-16 Positive Recurrent or Metastatic Malignancies (2L)	CT045
4	Pembrolizumab + Standard of Care (SOC) ± MK-4830	Merck & Co	MK-4830-002: Phase II study of pembrolizumab + chemotherapy ± MK-4830 as neoadjuvant treatment for high-grade serous ovarian cancer	Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer	CT046
5	JDQ443	Novartis Pharmaceuticals	A Phase II trial of JDQ443 in KRAS G12C-mutated NSCLC with PD L1 expression <1% or PD-L1 expression≥1% and an STK11 co-mutation	Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation (1L)	CT048
6	Nab-sirolimus	Aadi Bioscience	PRECISION I: Phase II, multicenter open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2	Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes	CT057
7	Savolitinib	Hutchmed	Phase II study of savolitinib in patients with METamplified gastroesophogeal junctio (GE) n adenocarcinomas or gastric cancer	Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients With MET Gene Amplifications (2L)	CT152
8	Cinrebafusp alfa + ramucirumab + paclitaxel	Pieris Pharmaceuticals	Combination of cinrebafusp alfa with ramucirumab and paclitaxel is well tolerated and elicits encouraging clinical activity in patients with HER2-positive gastric /GEJ adenocarcinoma in Phase II	HER2+ Gastric or GEJ Adenocarcinoma (3L)	CT154
9	Tisotumab vedotin	Seagen	innovaTV 207: Tisotumab vedotin in squamous cell carcinoma of head and neck (SCCHN): interim analysis from Phase II	Squamous cell carcinoma of head and neck	CT164
10	Telisotuzumab vedotin	AbbVie	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	c-Met+ Non-Small Cell Lung Cancer (2L/3L)	CT214

Phase II Abstracts Presenting at AACR 2023

Post Amgen’s Lumakras and Mirati’s Krazati’s approval in targeting KRAS mutations, 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 focus on targeting the RAF pathway.

S.No	Drug	Company	Title	Patient segment	Abstract
1	LY3537982	Eli Lilly and Company	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	KRAS G12C-Mutant Advanced Solid Tumors	CT028
2	GDC-6036 + cetuximab	Genentech/Roche	Phase Ib study of GDC-6036 in combination with cetuximab in patients with colorectal cancer (CRC) with KRAS G12C mutation	Colorectal cancer with KRAS G12C mutation	CT029
3	IBI351 (GFH925)	Genfleet Therapeutics	Phase I study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors: Updated results of the phase I study	Advanced Solid Tumors With KRAS G12C Mutations	CT030
4	BGB-3245	MapKure	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	Advanced or Refractory Tumors	CT031
5	Exarafenib (KIN-2787)	Kinnate Biopharma	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	BRAF/NRAS-mutated advanced or Metastatic Solid tumors	CT032
6	BGB-283 (lifirafenib) + PD-0325901 (mirdametinib)	BeiGene/SpringWorks Therapeutics	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	Patients With Advanced or Refractory Solid Tumors	CT033

KRAS Pathway Abstracts Presenting at AACR 2023

S.No	Drug	Company	Title	Patient segment	Abstract
1	Sacituzumab govitecan + zimberelimab + etrumadenant	Gilead Sciences	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)	Advanced or mNSCLC (1L)	CT049
2	Imvotamab + ZYNLONTA (loncastuximab tesirine)	IGM Biosciences	A phase I/II randomized study of imvotamab monotherapy and in combination with loncastuximab tesirine in relapsed/refractory non-Hodgkin lymphomas	Relapsed or Refractory B Cell NHL (3L+)	CT052
3	Datopotamab deruxtecan ± Anticancer Agents	AstraZeneca/Daiichi Sankyo	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	Advanced or Metastatic Solid Tumours	CT058
4	Pembrolizumab ± sacituzumab govitecan	Merck & Co/Gilead Sciences	Pembrolizumab with and without sacituzumab govitecan as first line treatment for metastatic non-small-cell lung cancer (NSCLC) with PD-L1 TPS ≥50%: phase III KEYNOTE-D46/EVOKE-03 study	Participants With PD L1 TPS Greater Than or Equal to ≥50% mNSCLC (1L)	CT067
5	AL102	Ayala Pharmaceuticals	Double-blind placebo-controlled trial of AL102 for treatment of progressing desmoid tumors: the RINGSIDE phase III study design	Patients With Progressing Desmoid Tumors (1L+ , 2L+)	CT070