Rapid Readouts

Dr. Garassino presents 5-year results from the EMPOWER-Lung 1 trial, discussing cemiplimab monotherapy's long-term survival benefits in advanced NSCLC patients with PD-L1 expression ≥50%.

Dr. Sara A. Hurvitz presents the primary results from the DESTINY-Breast12 trial, highlighting the efficacy and safety of trastuzumab deruxtecan in patients with HER2-positive advanced/metastatic breast cancer, including those with stable or active brain metastases​.

Dr. Lan Coffman presents updated Phase III MIRASOL trial results comparing overall survival and safety outcomes of mirvetuximab soravtansine (MIRV) versus investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer and high folate receptor-alpha expression.

Dr. Alexander Drilon presents an update from the Phase 1/2 ALKOVE-1 study, investigating the efficacy and safety of NVL-655, a selective ALK inhibitor, in patients with ALK-positive solid tumors, highlighting durable responses in heavily pre-treated populations, including those with compound ALK resistance mutations and central nervous system involvement.

Dr. Martin Dietrich presents updated efficacy and safety data from the Phase 2 PHAROS study, evaluating encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic non-small cell lung cancer, showing sustained clinical activity and a consistent safety profile after extended follow-up.

Dr. Pankit Vachhani presents key data from the CYTO-PV and MAJIC-PV studies, evaluating the efficacy of ruxolitinib versus best available therapy in patients with polycythemia vera, focusing on clinical outcomes such as cardiovascular risk reduction, hematocrit management, and long-term molecular responses.

Dr. Lorenza Rimassa presents a five-year overall survival analysis from the Phase 3 HIMALAYA study, demonstrating sustained survival benefits of the STRIDE regimen versus sorafenib in patients with unresectable hepatocellular carcinoma (uHCC).

Dr. Saad Usmani discusses the results of the Phase 3 CEPHEUS study, which evaluated the combination of daratumumab with bortezomib/lenalidomide/dexamethasone (D-VRd) in transplant-ineligible or transplant-deferred patients with newly diagnosed multiple myeloma, highlighting its impact on progression-free survival and minimal residual disease negativity.

Dr. Rafael Fonseca presents the primary results of the phase 3 AURIGA study, which demonstrates the significant improvement in MRD-negative conversion and progression-free survival with subcutaneous daratumumab plus lenalidomide versus lenalidomide alone as maintenance therapy in newly diagnosed multiple myeloma post-transplant, shared at the 2024 International Myeloma Society Annual Meeting.

The ARROS-1 Phase 1/2 study investigates the safety, tolerability, and efficacy of zidesamtinib (NVL-520), a ROS1-selective, brain-penetrant tyrosine kinase inhibitor, in heavily pre-treated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) and other solid tumors, showing promising durable responses in both systemic and intracranial disease.

Maurice Pérol, MD, presents a pooled analysis of two pivotal Phase 2 trials assessing the efficacy and safety of taletrectinib in patients with advanced ROS1+ non-small cell lung cancer.

Dr. Xiuning Le highlights real-world data on therapeutic outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations, emphasizing the need for improved treatments, at ESMO Congress 2024.

Everett E. Vokes, MD, FASCO, from University of Chicago Medicine, presents interim results from a phase 3 trial comparing petosemtamab plus pembrolizumab versus pembrolizumab monotherapy for first-line treatment of recurrent/metastatic PD-L1-positive head and neck squamous cell carcinoma at the 2024 ESMO Annual Meeting.

Scott Plotkin, MD, reviews data from a phase II study on brigatinib, a multi tyrosine kinase inhibitor, across various tumor types in patients with NF2-related schwannomatosis.

David Miller, MD, reviews a plenary presentation (originally presented at the ASCO 2024 Annual Meeting by Vikky Makker, MD) on the long-term follow-up of the ENGOT-EN5/GOG-3055/SIENDO trial, focusing on selinexor maintenance for patients with TP53 wild-type advanced or recurrent endometrial cancer.

VICTORIA (NCT05192642), is an exact-matching study comparing the outcomes of patients with TRK fusion cancer treated with larotrectinib in 3 clinical trials (NCT02122913, NCT02576431, NCT02637687) to patients treated with non-TRK inhibitor therapies in the real-world (RW) setting.

Misako Nagasaka, MD, PhD, discusses the use of trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer and recent NCCN guideline updates based on the DESTINY-Lung-01 HER2 overexpression cohort data.

BGB-11417-101 is a global phase 1/1b study evaluating sonrotoclax as monotherapy, or in combination ± zanubrutinib, and ± obinutuzumab in patients with B-cell malignancies. (NCT04277637)

A Phase 1b study (NCT03013998) to determine the safety and recommended dose of Revumenib combined with Aza/Ven in patients with newly diagnosed AML ≥ 60 years old with NPM1mut or KMT2Ar and who are not candidates or do not wish to pursue intensive induction therapy.

The aim of this study is to describe the demographic, clinical, and treatment characteristics of patients with LRMDS who were managed by physicians at Florida Cancer Specialists & Research Institute (FCS) and treated with ESAs, and to determine the proportion of LR-MDS patients who experience ESA failure and describe treatment patterns following ESA failure.

Preliminary results for treatment with zanubrutinib + venetoclax in patients with high-risk TN CLL/SLL with del(17p) and/or TP53 mutation showed Promising efficacy in a high-risk population with deep and durable responses according to data from arm D of the phase 3 SEQUOIA trial (NCT03336333).

BGB-16673-101 (NCT05006716) is a phase 1 study of a bruton tyrosine kinase degrader (BGB-16673) in patients with relapsed or refractory CLL/SLL.

DREAMM-8 (NCT04484623) is an ongoing, randomized, open-label, phase 3 study evaluating BPd vs PVd in patients with RRMM previously treated with ≥1 line of therapy including lenalidomide.

An economic analysis of Zanubrutinib versus Acalabrutinib and associated QoL benefits in AE management in patients with B-cell malignancies.

The study assessed the comparative efficacy of zanubrutinib vs acalabrutinib in patients with R/R MCL, in the absence of head-to-head clinical trials, using population-adjusted indirect treatment comparison via simulated treatment comparison approach. Data source for the efficacy of zanubrutinib was informed by the pooled individual patient-level data from 2 clinical trials: BGB-3111-206 (NCT03206970) and BGB-3111-AU-003 (NCT02343120). The efficacy of acalabrutinib was informed by the published aggregated data of the ACE-LY-004 trial (NCT02213926).

A phase 3, randomized, double-blind, placebo-controlled study to determine if prior TAS-102 and/or regorafenib treatment status and sequence affect the efficacy and safety of fruquintinib in patients with mCRC. This study used data from both FRESCO (NCT02314819) and FRESCO-2 (NCT04322539).

DREAMM-7 (NCT04246047) is a global, randomized, open-label, phase III head-to-head trial evaluating the efficacy and safety of BVd triplet vs SoC triplet, DVd, in patients (pts) with RRMM with ≥1 prior line of therapy.

Zanidatamab is a HER2-targeted bispecific antibody that binds to two non-overlapping HER2 domains and crosslinks neighboring HER2 proteins. In the primary analysis of the phase 2b HERIZON-BTC-01 trial (NCT04466891), after a median follow-up of 12.4 months, zanidatamab showed encouraging antitumor activity with rapid and durable responses and a manageable safety profile in patients with previously treated HER2+ BTC.

Tropion-Lung05 (NCT04484142) is a phase 2, multicenter, single-arm, open-label study evaluating Dato-DXd in patients with advanced/metastatic NSCLC with actionable genomic alterations who have progressed on or after targeted therapy and platinum-based CT.

Dr. Aditya Bardia presents the findings of DESTINY-Breast06 (NCT04494425) in chemotherapy naive patients with HER2-low and HER2-ultra low metastatic breast cancer demonstrating progression-free survival of trastuzumab deruxtecan compared to chemotherapy treatment of physician’s choice.