On June 3, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of a poster regarding MCLA-129 presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago May 31-June 4, 2024 (Press release, Merus, JUN 3, 2024, View Source [SID1234644033]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"These data continue to support our view that MCLA-129 is a very active drug, and that our Biclonics platform really can create clinically active drugs for patients with cancer. We plan to start a cohort investigating MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC later this year," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We continue to evaluate MCLA-129 with a focused investment and remain interested in a partnership to resource the further development of this asset."
Poster presentation title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in non-small-cell lung cancer (NSCLC) with Hepatocyte Growth Factor Receptor (c-MET) exon 14 skipping mutations (METex14)
Observations in the presentation include:
As of a February 16, 2024 data cutoff date, 22 patients (pts) were treated and 14 pts (64%) were continuing treatment
All the pts received MCLA-129 in monotherapy at the dose of 1500 mg, every 2 weeks
Pts received a median of 2 lines of prior therapy
10 pts (45%) were tyrosine kinase inhibitor (TKI)-naïve and 12 (55%) had received prior TKIs
7 pts were excluded from the efficacy population. 4 discontinued due to AEs <2 cycles of treatment and did not experience progressive disease while on study; 3 were ongoing as of the cutoff date with <2 treatment cycles
15 pts were evaluable for response having received ≥2 treatment cycles, measurable disease at baseline and ≥1 post-baseline scan
Response rate overall: 3 partial responses (PRs) and 6 unconfirmed PRs (uPRs) were observed by Response Evaluation Criteria in Solid Tumors v1.1 per investigator assessment; 5 of the 6 uPRs were confirmed and 1 uPR progressed after the data cutoff (8/15 confirmed PRs [53%])
6 of 8 TKI-naïve cancers responded, one of which was an initial uPR that progressed after data cutoff
3 of 7 cancers with prior MET TKI responded
Reduction in target lesion tumor size from baseline was demonstrated in 12 pts (80%)
Early safety assessment in 22 pts treated with MCLA-129 monotherapy included
Infusion related reactions (composite term) in 86% (18% ≥ Grade (G)3)
One pt had treatment-related interstitial lung disease (G2)
Venous thromboembolism was recorded in 2 pts (1 G3 possibly treatment-related, the other G2 and not related to treatment)
The full presentation is available on the Publications page of our website.
MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains global rights outside of China. An abstract sponsored by Betta entitled: Efficacy and safety of MCLA-129, an EGFR/c-MET bispecific antibody, in advanced non-small cell lung cancer (NSCLC) was accepted for poster presentation at 2024 ASCO (Free ASCO Whitepaper).