American Association for Cancer Research (AACR) 2023 Preview – Top Data Readouts
Apr 14, 2023 |
Reading Time: 5minutes
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
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
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 bylaunching 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
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’sapproval 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
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)
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