As the curtain rises on ESMO 2023, the pharmaceutical giants, such as Merck, Roche, Bristol-Myers Squibb, BeiGene, AstraZeneca, and more, are poised to dazzle the audience with groundbreaking data readouts of their promising new drug candidates. With an air of excitement, industry leaders are eagerly anticipating the potential treatment breakthroughs to be unveiled during the event. 

Early-stage NSCLC Highlights

• Abstract Number – #LBA56

• Abstract Type – Proffered Paper Session 
• Indication – NSCLC
• Target – Early-stage NSCLC

Title: Merck to Present the Full Results of its Recently Approved Blockbuster Drug in the Perioperative Setting

Executive Summary – In the pivotal KEYNOTE-671 Phase III trial for resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC, neoadjuvant and adjuvant KEYTRUDA plus chemotherapy revealed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo-based strategies. KEYTRUDA's safety profile remained consistent with previous studies, with no new safety concerns.

Main Content –  The blockbuster drug of Merck once again made the headlines after its remarkable approval in the perioperative setting. The approval was based on KEYNOTE-671, a randomized, double-blind Phase III trial evaluating neoadjuvant KEYTRUDA plus chemotherapy, followed by adjuvant KEYTRUDA as a single agent versus placebo plus neoadjuvant chemotherapy, followed by adjuvant placebo in patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC. At a pre-specified interim analysis, KEYTRUDA plus chemotherapy before surgery (neoadjuvant), followed by resection and KEYTRUDA as a single agent after surgery (adjuvant), demonstrated a statistically significant and clinically meaningful improvement in OS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients. At 24 months, the event-free survival rate was 62.4% with KEYTRUDA plus chemotherapy and adjuvant KEYTRUDA vs 40.6% and the major pathologic response (mPR) rate was 30.2%. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. In October 2023, the US FDA approved KEYTRUDA with platinum-containing chemotherapy as neoadjuvant treatment, and with the continuation of single-agent KEYTRUDA as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node-positive) NSCLC.

The comprehensive findings from this analysis of KEYNOTE-671 are slated for presentation at the ESMO conference.

• Abstract Number – #LBA2

• Abstract Type – Proffered Paper Session 
• Indication – NSCLC
• Target – Early-stage ALK+ NSCLC

Title – Roche to Unveil the Full Results of ALINA Phase III Study at the ESMO 2023 Presidential Symposium

Executive Summary - The ALINA study, a Phase III trial, revealed a significant 76% reduction in disease recurrence or mortality when comparing adjuvant ALECENSA to platinum-based chemotherapy in patients with resected Stage IB to IIIA ALK-positive NSCLC. Notably, it also demonstrated a substantial improvement in central nervous system disease-free survival (CNS-DFS), with consistent safety profiles.

Main Content – The ALINA study a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant ALECENSA (alectinib) compared with platinum-based chemotherapy in people with completely resected Stage IB to IIIA ALK-positive NSCLC. The trial showed a significant and clinically meaningful enhancement in Disease-Free Survival (DFS), the primary endpoint of the study.

The study findings demonstrated a remarkable 76% reduction in the risk of disease recurrence or mortality when compared to platinum-based chemotherapy for those diagnosed with completely resected Stage IB to IIIA ALK-positive NSCLC.

Moreover, the study highlighted a substantial improvement in Central Nervous System Disease-Free Survival (CNS-DFS). It is worth noting that ALECENSA's safety and tolerability profiles in this trial remained in line with prior assessments in the metastatic context, with no unexpected safety concerns observed by the company. The data from this study will be featured as a late-breaking oral presentation at the ESMO 2023 Presidential Symposium.

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.