ESMO Asia 2023 is just around the corner, and leading pharmaceutical giants like Janssen, Astellas Pharma, Seagen, Bayer, and others are gearing up for this conference. The ESMO Asia 2023 will delve into the latest breakthroughs across various cancer types, both globally and within the Asia-Pacific region. The industry leaders are meticulously preparing to unveil data insights and in-depth analyses poised to steal the spotlight, capturing the attention of the audience. 

This content focuses on giving an overview of the some of the promising abstracts from the field of Genitourinary Cancers that will be showcased at the forthcoming ESMO Asia conference.

Genitourinary Cancer Highlights

• Abstract Number – 258MO
• Abstract Type – Mini Oral Session
• Indication – Metastatic hormone-sensitive prostate cancer (mHSPC)

Title: Darolutamide (DARO) in combination with androgen-deprivation therapy (ADT) and docetaxel (DOC) in Chinese patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) in the Phase III ARASENS study

Executive Summary: In Chinese patients with mHSPC, the combination of DARO with ADT and DOC not only enhanced overall Survival (OS) but also delayed the onset of Castration-Resistant Prostate Cancer (CRPC) and PSA progression. Additionally, the safety profile of this combination mirrored that of the placebo (PBO) when administered with ADT and DOC, aligning with findings in the broader ARASENS population.

Main Content: Based on results from the ARASENS trial, NUBEQA (darolutamide) has obtained approval in China for use in combination with ADT and DOC in patients with mHSPC. The study has been completed, and the outcomes detailing efficacy and safety will be presented at the upcoming ESMO Asia conference.

In this study, participants were administered either DARO at a dosage of 600 mg twice daily or a placebo (PBO) alongside ADT and DOC, with OS as the primary focus. Secondary and exploratory endpoints encompassed metrics such as time to CRPC, time to PSA progression, PSA responses, specifically a ≥90% PSA decrease from baseline (PSA90%), and considerations of safety.

Among the 1,305 assessable patients, 202 hailed from mainland China and in that cohort, DARO exhibited a 36.4% reduction in the risk of mortality compared to PBO. Additionally, favorable outcomes were observed for DARO in terms of time to CRPC and time to PSA progression. A higher proportion of DARO recipients achieved undetectable PSA (<0.2 ng/mL: 71.2% vs. 19.4%) and PSA90 (87.5% vs. 69.4%) at any given time. The incidence of Treatment-Emergent Adverse Events (TEAEs) was comparable between the DARO and PBO groups, with neutropenia being the most prevalent Grade 3/4 TEAEs (DARO 63.8% vs. PBO 61.5%; Grade 3/4 febrile neutropenia 5.7% vs. 2.1%, respectively).

• Abstract Number – 211MO
• Abstract Type - Mini Oral Session
• Indication – Metastatic urothelial carcinoma

Title: EV-302/KEYNOTE-A39: Open-label, randomized Phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs. chemotherapy (chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC)

Executive Summary: The combination of PADCEV and KEYTRUDA yielded significant improvements as per the results of trial being conducted in individuals with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), with both median progression-free survival (PFS) and overall survival (OS) nearly doubling in comparison to conventional chemotherapy.

Main Content: Currently, platinum-based chemotherapy stands as the established standard of care (SoC) for locally advanced or metastatic urothelial carcinoma (la/mUC). However, there persists an unmet need due to the suboptimal long-term outcomes. This paves way for EV-302, a Phase III global study that assesses the combination of PADCEV and KEYTRUDA in individuals with previously untreated la/mUC who qualify for chemotherapy containing cisplatin or carboplatin.

In this study, 886 participants underwent randomization, and as of the data cutoff, the median follow-up duration was 17.2 months. The combination treatment exhibited a significant extension in PFS, reducing the risk of progression or death by 55% compared to chemotherapy. Moreover, OS was notably prolonged with the drug combination, decreasing the risk of death by 53% in contrast to chemotherapy. The confirmed ORR stood at 67.7% for the PADCEV and KEYTRUDA combination, surpassing the 44.4% observed in the chemotherapy arm. Grade ≥3 TRAEs occurred in 55.9% of cases with the PADCEV and KEYTRUDA combination, while chemotherapy reported a higher incidence at 69.5%. These compelling findings strongly advocate for the combination as an impactful new standard of care for the initial treatment of locally advanced or metastatic urothelial carcinoma (la/mUC). It would be interesting to see the detailed analysis of the combination, which is going to be presented at the ESMO Asia 2023 conference.

 

List of Abstracts to be presented at ESMO Asia 2023