ESMO Asia 2023 is on the horizon, and prominent pharmaceutical entities like Janssen, Daiichi Sankyo, Takeda, Roche, and others are poised for the conference, ready to unveil data readouts and conclusive analyses. 

In 2022, Japan accounted for ~23% of incident cases of NSCLC of the total cases in the 7MM region. This content focuses on important abstracts on NSCLC that are anticipated to create a substantial impact over due course of time.

Lung Cancer Highlights

• Abstract Number – 508MO
• Abstract Type - Mini Oral session
• Indication – SCLC

Title: Tarlatamab for patients (pts) with previously treated small cell lung cancer (SCLC): Primary analysis of the Phase II DeLLphi-301 study

Executive Summary – Tarlatamab presents a promising immunotherapeutic avenue in the Phase II study for SCLC by targeting both Delta-like ligand 3 (DLL3) on cancer cells and Cluster of Differentiation 3 (CD3) on T cells. The study has demonstrated encouraging outcomes.

Main Content: 

Tarlatamab, a bispecific T-cell engager (BiTE), has demonstrated favorable outcomes in treating small-cell lung cancer (SCLC) by binding to DLL3 on SCLC cells and CD3 on T cells, resulting in the eradication of tumors through T-cell-mediated lysis. Initial findings from a Phase I study were promising, and currently, the results from a Phase II study are anticipated, involving patients who relapsed after one platinum-based regimen and at least one additional prior therapy.

The investigation revealed that, with a 10 mg dosage, there was a 40% objective response rate (ORR), a median progression-free survival (mPFS) of 4.9 months, and a median overall survival (OS) of 14.3 months. The median duration of response was not reached. Additionally, the study observed that the 10 mg dose of tarlatamab was correlated with a superior ORR and extended median PFS when compared to the 100 mg dose. Additional insights are expected to be disclosed at the ESMO Asia 2023 conference.

• Abstract Number – 509MO
• Abstract Type - Mini Oral Session
• Indication – NSCLC

Title: Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): Results of the randomized Phase III study TROPION-Lung01

Executive Summary – Datopotamab deruxtecan (Dato-DXd), an investigational ADC by Daiichi Sankyo targeting TROP2, exhibits promising results in a comprehensive analysis in Phase III study.

Main Content:

Datopotamab deruxtecan (Dato-DXd) is an investigational antibody-drug conjugate (ADC) targeting TROP2, developed using Daiichi Sankyo’s exclusive DXd ADC technology. It is one of the forefront ADCs within Daiichi Sankyo’s oncology pipeline. The comprehensive analysis involved 604 patients in the full analysis set (FAS), with 43.1% having received a minimum of two prior lines of systemic therapy. Dato-DXd exhibited a noteworthy enhancement in progression-free survival (PFS). Confirmed overall response rates (ORRs) were 26.4% for Dato-DXd, and 12.8% for DTX, with respective median duration of response of 7.1 and 5.6 months. This marks the initial disclosure from the TROPION-Lung01 Phase III study comparing Dato-DXd to docetaxel in previously treated patients with advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations (AGAs), with results to be presented at ESMO Asia 2023.

 

• Abstract Number – 510MO
• Abstract Type - Mini Oral session
• Indication – NSCLC

Title: Trastuzumab deruxtecan (T-DXd) in Asian patients (Pts) with human epidermal growth factor receptor 2 (HER2; ERBB2)-mutant (HER2m) metastatic non-small cell lung cancer (mNSCLC): Subgroup analysis of DESTINY–Lung02 (DL-02)

Executive Summary – Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate for HER2-mutated mNSCLC, by Daiichi Sankyo and AstraZeneca demonstrated notable therapeutic efficacy in Phase II DESTINY–Lung02 clinical trial.

Main Content:

Trastuzumab deruxtecan, an antibody-drug conjugate comprising an anti-HER2 antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor, has demonstrated substantial therapeutic efficacy in patients previously treated for HER2-mutated mNSCLC.

Among the study participants, sixty-three Asian patients were administered T-DXd at a dose of 5.4 mg/kg, while 30 received it at 6.4 mg/kg. The confirmed overall response rates (cORR) for T-DXd at 5.4 mg/kg and 6.4 mg/kg were recorded at 50.8% and 73.3%, respectively. The median duration of response (DoR) was established at 16.8 months. This subgroup analysis affirms the robust and enduring responses observed with both doses of T-DXd, coupled with manageable safety, in the Asian patient cohort. T-DXd at 6.4 mg/kg demonstrated a numerically higher response, albeit with an elevated incidence of interstitial lung disease (ILD). In contrast, T-DXd at 5.4 mg/kg exhibited a lower ILD incidence and generally presented a more favorable benefit/risk profile. These findings are consistent with the trends observed in the overall population, endorsing the preference for T-DXd at 5.4 mg/kg in Asian patients. A comprehensive analysis of the results will be presented at the ESMO Asia 2023 conference.

• Abstract Number – 511MO
• Abstract Type - Mini Oral session
• Indication – NSCLC

Title: A Phase I study of SHR-1701, a bifunctional fusion protein targeting PD-L1 and TGF-β, in patients with advanced non-small cell lung cancer (NSCLC)

Executive Summary – SHR-1701, a bifunctional fusion protein, by Jiangsu Hengrui Pharmaceuticals, demonstrated promising outcomes in Phase I clinical trial in three cohorts of advanced/metastatic NSCLC patients, including those with no prior chemotherapy, EGFR mutations, and post anti-PD-1/PD-L1 therapy progression.

 

Main Content:

SHR-1701 is a dual-acting fusion protein, combining an anti-PD-L1 antibody with the extracellular domain of TGF-β receptor II. The study's clinical expansion involved three cohorts of patients with advanced/metastatic NSCLC. Cohort 1 included individuals without prior systemic chemotherapy and a PD-L1 Tumor Proportion Score (TPS) of ≥1%, Cohort 2 comprised patients with EGFR mutations who had failed standard EGFR TKIs or lacked access to such treatments, and Cohort 3 included those progressing after recent anti-PD-1/PD-L1 therapy, having undergone up to three prior lines of treatment. Eligible patients received SHR-1701 at 30 mg/kg every three weeks. In total, 131 patients participated, distributed across Cohorts 1, 2, and 3. The majority (84.0%) were in stage IV, with 45.0% having three or more metastatic sites. Median follow-up durations for Cohorts 1, 2, and 3 were 20.3 months, 14.3 months, and 14.8 months, respectively. Cohort-specific objective response rates (ORR) were 36.8%, 19.5%, and 9.1% for Cohort 1, 2 and 3 respectively. A thorough analysis of the results will be presented at the ESMO Asia 2023 conference. 

List of Abstracts to be presented at ESMO Asia 2023