MacroGenics Announces Presentation of MGD019 Phase 1 Data at the ESMO Virtual Congress 2020

  • MGD019 well-tolerated with early signals of activity in advanced solid tumors not typically responsive to checkpoint inhibition
  • Recommended Phase 2 dose established for MSS CRC, NSCLC expansion cohorts
  • Presentation is available on-demand as part of the ESMO Virtual Congress 2020 

ROCKVILLE, MD, USA I September 20, 2020 I MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019. The proffered paper session titled, “A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD019, an Investigational Bispecific PD-1 × CTLA-4 DART® Molecule in Patients with Advanced Solid Tumors,” was presented orally at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 20, 2020, by Dr. Manish R. Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan.

MGD019, a bispecific PD-1 × CTLA-4 DART molecule, was designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells. 

Forty-three patients were enrolled in the Phase 1 dose escalation study of MGD019 within a dose range of 0.03 – 10.0 mg/kg, administered every three weeks initially, in a population of heavily pre-treated patients representing a broad range of different types (23) of solid tumors. There were no dose-limiting toxicities (DLTs). A total of 28 patients were treated at doses ≥ 3.0 mg/kg administered every three weeks initially. MGD019 was well-tolerated in patients who received less than 10 mg/kg; the most common treatment-related adverse events over this dosing range were pruritus (23.3%), arthralgia (18.6%), fatigue (18.6%), rash (18.6%), nausea (16.3%) and infusion-related reaction (16.3%). Several Grade 3 adverse events were observed at the 10.0 mg/kg level; however, none were considered dose limiting.

In this study, sustained peripheral PD-1 blockade was evident at doses ≥ 1.0 mg/kg.  In addition, dose-dependent upregulation of the inducible costimulator (ICOS) molecule was evident in treated patients, including those who responded to MGD019 therapy.  This is consistent with the previously reported observation that anti-CTLA-4 therapy increases the frequency of CD4 T cells expressing the ICOS molecule.1

Of the 18 evaluable patients who received doses ≥ 3.0 mg/kg as of the July 21, 2020 cut-off date, four objective responses have been reported in this trial, including a confirmed complete response in metastatic castration-resistant prostate cancer (mCRPC), confirmed partial responses in microsatellite stable colorectal cancer (MSS CRC) and metastatic type AB thymoma, and an unconfirmed partial response in serous fallopian tube carcinoma.

“We are especially encouraged by the evidence of anti-tumor activity in patients treated with MGD019 who have cancers typically unresponsive to checkpoint inhibition. In addition, we are very pleased that MGD019 was well tolerated,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Based on the results presented today, we plan to expand the study initially in patients with MSS CRC and checkpoint-naïve non-small cell lung cancer at the recommended Phase 2 dose of 6.0 mg/kg.”

These results are available on-demand as part of the ESMO Virtual Congress 2020 Proffered Paper - Investigational Immunotherapy session on September 20, 2020 (Presentation # 1020O). In addition, Dr. Sharma’s slides can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at

About MGD019

MGD019 is an investigational bispecific DART molecule that was designed to enable co-blockade of two immune checkpoint molecules co-expressed on T cells, PD-1 and CTLA-4.

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

SOURCE: MacroGenics

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