ABBV-637, an innovative antibody-drug conjugate, combines an EGFR-focused antibody with a BCL-X inhibitor. Early research findings reveal that ABBV-637, when used in conjunction with osimertinib (OSI), shows strong antitumor effects on EGFR-mutated non-small cell lung cancer by reactivating the apoptotic pathway.

The Phase I open-label dose escalation and expansion study (Part 3) is a first-in-human trial aimed at assessing the safety and preliminary effectiveness of ABBV-637 when used as a second- and third-line combination therapy with osimertinib. This study is designed for patients with relapsed or refractory non-small cell lung cancer (NSCLC) who harbor an EGFR mutation, exhibit an ECOG performance status of 0-1, and have previously experienced both a positive response and subsequent disease progression while on osimertinib treatment. The dosing regimen involves administering ABBV-637 at 12 or 20 mg/kg intravenously every 4 weeks, complemented by daily osimertinib at 80 mg, within 28-day cycles. The primary objectives are to assess the rates of treatment-emergent adverse events (TEAEs) and the objective response rate (ORR). Additionally, secondary endpoints encompass evaluating the duration of response, progression-free survival, and overall survival outcomes in this patient population.

The table below summarizes the adverse events that emerged during the treatment in Part 3.

Combining ABBV-637 with osimertinib has demonstrated positive clinical results and manageable safety in individuals with relapsed or refractory NSCLC. Insights from biomarker data indicate that the effectiveness of ABBV-637 and osimertinib treatment may be enhanced by excluding patients with identifiable bypass mechanisms. However, further research is required to validate the link between specific mutations and patient selection.

KOL insights: “ABBV-637 showing promising clinical activity and a manageable safety profile in NSCLC.” - Ph.D, Cancer Discovery, US

Conclusion: ABBV-637, an innovative antibody-drug conjugate combining an EGFR-focused antibody with a BCL-X inhibitor, has shown early promise in its collaboration with osimertinib (OSI) for treating EGFR-mutated non-small cell lung cancer. Preclinical research indicates significant antitumor effects by reactivating the apoptotic pathway. The Phase I trial (Part 3), a first-in-human study, focuses on evaluating ABBV-637 as a second- and third-line therapy in patients with relapsed or refractory NSCLC harboring EGFR mutations. Preliminary findings indicate encouraging objective response rates and disease control rates, with manageable treatment-emergent adverse events (TEAEs). The outcomes suggest that ABBV-637, when combined with OSI, holds promise as a potential therapeutic option for this patient population, warranting further investigation and development.

NSCLC accounts for up to 85% of lung cancer. The total incident cases of EGFR NSCLC in the US was ~30,000 in 2022. The majority of the cases fall under EGFR exon 19 deletions followed by Exon 21 L858R substitution. DelveInsight estimates that the total market size of EGFR mNSCLC in the 7MM was ~USD 3,920 million in 2022.

For more insight into the patient's burden/epidemiology, treatment, and changing market landscape-related advancements, refer to the-Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) - Market Insight, Epidemiology And Market Forecast - 2032

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.