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What to expect at #ASCO2022?
The 2022 ASCO annual meeting program will offer insights into the latest research in cancer care, practice-changing trends, and incremental improvements and identify several new opportunities hidden in current challenges.
Equitable cancer care through innovation will remain a key theme at ASCO 2022, with several ground-breaking studies on new modalities, targets, and combinations. FutureBridge Oncology consulting team has identified transformative themes that will impact the future.Â
Transformative Themes
- Antibody Drug Conjugate (ADC) development leads the path
- Circulating DNA (ctDNA) adopts the role of a vital & versatile biomarker
- T Cell and beyond: Success of cell therapies transitioning in solid tumors
1. Antibody Drug Conjugates (ADC) developments lead the path
Recent FDA approval of Enhertu based on results from DESTINY-Breast03 is a validation of the increasing interest, investment, and expected growth of the antibody-drug conjugates (ADCs). The ASCO 2022 will feature >30 studies including continued development of established ADCs and the first in human studies of new ADCs.
Key presentations to watch include:
Breast cancer
- Enhertu (HER2 ADC) in HER2-low unresectable and/or metastatic breast cancer (Results of phase III DESTINY-Breast04)
- MRG002 (HER2 ADC) in HER2-low advanced or metastatic breast cancer.
- Patritumab deruxtecan (HER3 ADC) in HER3-expressing metastatic breast cancer: (Results from phase 1/2 study)
- Tucatinib + Enhertu in HER2positive locally advanced or metastatic breast cancer with/ without brain metastases (phase 2, HER2CLIMB-04)
- Enhertu ± anastrozole as neoadjuvant therapy for HER2-low, HR+ early-stage breast cancer (Phase 2, TRIO-US B-12 TALENT)
- Enhertu + other anti-cancer agents in advanced/metastatic HER2+ (DESTINY-Breast07 [DB-07]) and HER2-low (DESTINY-Breast08 [DB-08]) breast cancer
NSCLC
- Patritumab deruxtecan (HER3-ADC) in advanced/metastatic NSCLC without EGFR-activating mutations
- Patritumab deruxtecan + osimertinib in advanced EGFR-mutated NSCLC (phase 1 study)
- Enhertu in unresectable, locally advanced, or metastatic NSCLC harboring HER2 exon 19 or 20 mutations (Phase 3 DESTINY-Lung04)
GU cancers
- MRG002-ADC (HER2 ADC) for unresectable locally advanced or metastatic bladder cancer (Phase 2 study)
- RC48-ADC (HER2 ADC) + toripalimab in locally advanced or metastatic bladder cancer.
- FOR46 (CD46 ADC) in metastatic CRPC (Phase 1a/1b study)
GI cancers
- Enhertu in HER2-expressing unresectable or recurrent biliary tract cancer (An investigator-initiated phase 2 HERB trial)
- Enhertu as neoadjuvant treatment for HER2 +Â gastric and gastroesophageal junction adenocarcinoma (Phase 2, EPOC2003 trial)
Ovarian cancer
- STRO-002 (folate receptor alpha ADC) + bevacizumab in advanced epithelial ovarian cancer (phase 1, STRO-002-GM2)
Solid tumors
 SGN-PDL1V (PD-L1 ADC) in advanced solid tumors (phase 1, SGNPDL1V-001)
- SGN-ALPV (ALPP/ALPPL2 ADC) in advanced solid tumors (phase 1, SGNALPV-001)
- AZD8205 (B7-H4 ADC) in advanced/metastatic solid tumors (First in human study)
- ADCT-901(KAAG1 ADC) in select advanced solid tumors (First-in-human, phase 1 study)
- OBT076 (CD205Â ADC) in advanced/metastatic solid tumors ( a first-in-class phase 1 study)
CBP-1018 and CBP-1008 (bi-ligand-drug conjugate) in advanced solid tumors.(a phase I study)
2. Circulating DNA (ctDNA) adopts the role of a vital & versatile biomarker
Recently FDA released draft guidance for the industry on the use of circulating tumor DNA for early-stage solid tumor drug development. The guidance is intended to help sponsors planning to use ctDNA as a biomarker in cancer clinical trials and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage setting.
Several presentations at ASCO will focus on novel use of ctDNA in patient selection, as a marker for MRD for patient enrichment, as a measure of therapy response, and as an early endpoint in clinical trials.
Key presentations are
 Ct DNA as a non-invasive source for mutation analysis
- Complementary role for circulating tumor DNA and tumor tissue to detect clinical relevant alterations in patients with CRPC
- Using cell-free circulating tumor DNA (cfDNA) to identify guideline-relevant biomarkers for therapy selection in 14,000 patients (pts) with metastatic colorectal cancer (mCRC) (Abstract 3601 Poster 395)
- ESR1Â mutations in (ctDNA) are associated with CTCs and increased hormone receptors in metastatic tumor tissues of patients with metastatic breast cancer
CtDNA as a measure of therapy response
ü Largest evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated non–small cell lung cancer (NSCLC) and colorectal cancer (CRC): Plasma biomarker analysis of CodeBreaK100. (Abstract 102)
- Assessing the predictive value of ctDNA on relapse in patients with resected stage IB-IIIA NSCLC treated with adjuvant chemotherapy plus concomitant atezolizumab followed by atezolizumab: BTCRC LUN 19-396.
- CtDNA shed as a tool to select immune checkpoint inhibitors (ICPI) with or without chemotherapy for patients with advanced NSCLC
- Dynamic circulating tumor DNA (ctDNA) in monitoring trastuzumab deruxtecan (TDXd) activity for patients (pts) with advanced breast cancer: Preliminary results of a feasibility study.
- Longitudinal ctDNA whole-exome sequencing (WES) in the phase Ib/II trial of palbociclib and bazedoxifene reveals genomic dynamics and clonal evolution with the acquisition of treatment resistance in hormone receptor-positive, HER2-negative (HR+ HER2-), advanced breast cancer
- Circulating tumor DNA (ctDNA) and serum thymidine kinase 1 activity (TKa) matched dynamics in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2-) advanced breast cancer (ABC) treated in first-line (1L) with ribociclib (RIB) and letrozole (LET) in the BioItaLEE trial.
- ctDNA in treatment response monitoring in patients with relapsed gynecologic malignancies.
- Methylated circulating tumor DNA (cfMeDIP) as a predictive biomarker of clinical outcome in pan-cancer patients (pts) treated with pembrolizumab (P).
- Circulating tumor DNA (ctDNA) analyses of the phase III VOYAGER trial: KIT mutational landscape and outcomes in patients with advanced gastrointestinal stromal tumor (GIST). (Abstract 101)
CT DNA in MRD analysis
- MRD detection by ctDNA in relation to radiographic disease progression in patients with stage I-III NSCLC treated with definitive radiation therapy.
- Leveraging personalized ctDNA for detection and monitoring of MRD in high-risk melanoma.
- ctDNA detection of MRD as a potential biomarker in localized STS
- NSAB C-14: CORRECT-MRD II—Second colorectal cancer clinical validation study to predict recurrence using a circulating tumor DNA assay to detect minimal residual disease (Abstract TPS3632 Poster 424a)
CT DNA as marker of recurrence
- Personalized ctDNA analysis in patients with recurrent/metastatic HNSCC
- Postoperative ctDNA in indicating the recurrence risk and monitoring the effect of adjuvant therapy in surgical NSCLC.
- ctDNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer (CHiRP).
- Copy number aberration burden on circulating tumor DNA predicts recurrence risk after neoadjuvant chemotherapy in patients with triple-negative breast cancer: Post-hoc analysis of phase III PEARLY trial.
Other presentations on the use of CTDNA biomarker
Circulating Tumor DNA: An Emerging Tool in Gastrointestinal Cancers
- Real-world utilization of ctDNA in the management of colorectal cancer.
- Novel use of ctDNA to identify muscle-invasive and non-organ-confined upper tract urothelial carcinoma.(Abstract 4587 Poster 78)
- Clinical utility of circulating tumor DNA sequencing with a large panel in patients with advanced soft-tissue sarcomas. (Abstract11550 Poster 454)
- NK cell activity and methylated HOXA9 circulating tumor DNA as prognostic biomarkers in patients with non-small cell lung cancer treated with PD-1/PD-L1 inhibitors. (Abstract 2552 Poster 207)
- Next-generation sequencing (NGS) of circulating cell-free DNA (cfDNA) in patients (pts) with advanced hepatocellular carcinoma (HCC) (Abstract 4110 Poster 97)
3. T Cell and beyond: Success of cell therapies transitioning in solid tumors
70 presentations ranging from updates from late-phase trials to first in human studies in solid and heme malignancies
Key highlights in heme malignancies
Gilead and Kite Oncology to project CAR-T cell therapy developments
New Sub-analysis to be presented from Kite’s ZUMA-7 CAR T-cell Therapy Study in Patients Aged 65+ and Data by Tumor Burden Characteristics in Second-Line Large B-cell Lymphoma
- Legend Biotech will showcase Continued Progress in the Treatment of Multiple Myeloma With Updated Data From BCMA CAR-T Studies
Gracell Biotechnologies to Present Clinical Data on BCMA/CD19 Dual-targeting CAR-T GC012F in RRMM. CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted, and show enhanced proliferation, persistence, bone marrow migration, and tumor cell clearance with next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency
- NKARTA to report positive preliminary dose-finding data for two lead engineered natural killer cell programs
- Autologous CD19-directed CAR T cells produced by the novel PrimeCARÂ manufacture platform exhibit safety, efficacy, and long persistence profiles in relapsed/refractory B-lineage acute leukemia (r/r B-ALL).
- Decreasing HPK1 expression in CD19 CAR-T cells:Â A novel strategy to overcome challenges of cell therapy for adult (r/r) B-ALL. (Abstract 7041)
- CRC-403: A phase 1/2 study of bbT369, a dual-targeting CAR T-cell drug product with a gene edit, in relapsed and/or refractory B-cell non-Hodgkin lymphoma (NHL). (Abstract TPS7580 Poster 231b)
- Phase 1/2 study of anbalcabtagene autoleucel, novel anti-CD19 CAR-T cell therapy with dual silencing of PD-1 and TIGIT in relapsed or refractory large B-cell lymphoma (Abstract 7522, Poster 176)
- Autologous CD7-targeted CAR T-cell therapy for refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma. (Abstract 7035)
- CAR T-cells effective for post-CART relapse: A new treatment paradigm.
Key highlights in solid tumors
- Safety, tolerability, and preliminary efficacy results in patients with advanced gastric/gastroesophageal junction adenocarcinoma from a phase Ib/II study of CLDN18.2 CAR T-cell therapy (CT041). (Abstract 4017 Poster 5)
- Phase 2 Quilt 88 trial of DAMP inducers combined with IL15 superagonist, N-803, and anti–PD-L1 NK cell therapy more than doubles historical overall survival in patients with third- to sixth-line advanced pancreatic cancer. (Abstract 4147 Poster 131)
- Glypican-3-specific CAR-NKT cells overexpressing BATF3 mediate potent antitumor activity against hepatocellular carcinoma.
- A phase 1 dose-escalation study of GCC19 CART a novel coupled CAR therapy for subjects with metastatic colorectal cancer (Abstract 3582 Poster 376)
A phase 1 first-in-human dose-finding/randomized phase 2 study of IMM60 and pembrolizumab (PEM) in advanced melanoma and non–small cell lung cancer (NSCLC; IMP-MEL) (Abstract 2582 Poster 237)
- Phase I/II first-in-human CAR T–targeting MUC1 transmembrane cleavage product (MUC1*) in patients with metastatic breast cancer
- A phase 1, first-in-human (FIH) study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors. (Abstract TPS2677 Poster 327b)
- Phase I clinical safety and efficacy observation of αPD-1-mesoCAR-T cells in the treatment of advanced gynecologic cancer.
- Phase I clinical trial to assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of NY-ESO-1–specific TCR T-cells (TAEST16001) in HLA-A*02:01 patients with advanced soft tissue sarcoma. (Abstract 11502)
- Merkel polyoma virus-specific T-cell receptor transgenic T-cell therapy in PD-1 inhibitor refra
Racial/ethnic disparities in locoregional recurrence in hormone-receptor positive node-negative breast cancerctory Merkel cell carcinoma. (Abstract 9549 Poster 142) - DELTA-1: A global, multicenter, phase 2 study of ITIL-168, an unrestricted autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in adult patients with advanced cutaneous melanoma. (Abstract TPS9594 Poster 185b)
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