dm+d
Unassigned
New Medicines
MargenzaMetastatic breast cancer, HER2-positive - third-line
Information
Margenza
New molecular entity
MacroGenics
MacroGenics
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Launched
Nov 21MacroGenics has a license agreement with Zai Lab to develop and commercialise margetuximab in China, Hong Kong, Macau and Taiwan. No agreements yet in place to develop and commercialise in Europe [16].
Mar 21MacroGenics and Eversana launch margetuximab (Margenza), in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in the US [15].
Dec 20According to its latest annual report, outside the United States, MacroGenics ´ strategy is to enter into arrangements with third-party commercial partners for any of its product candidates that obtain marketing approval [12].
Dec 20Approved in US [10].
Dec 19MacroGenetics announced the submission of a BLA for margetuximab in treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy [9].
Sep 16PIII [1].
Category
Fc-optimised chimeric second-generation anti-HER2 monoclonal antibody. Margetuximab has been engineered to increase the affinity of the Fc domain for both CD16A alleles and decrease the affinity for the inhibitory receptor, FcγRIIB.
44,266 new cases of breast cancer in the UK in 2010. 90-95% of patients present with localised (stage I-III) disease and are eligible for surgery and adjuvant treatment and ~15-25% have HER-2 positive cancer [4].
Metastatic breast cancer, HER2-positive - third-line
Intravenous infusion
Trial or other data
Sep 21Final overall survival (OS) analysis of PIII SOPHIA study showed no statistically significant advantage of margetuximab vs. trastuzumab plus chemotherapy. Median OS was 21.6 months with margetuximab plus chemotherapy vs. 21.9 months with trastuzumab plus chemotherapy. However, there greater OS was observed in the CD16A subgroup of pts with the lowest binding allelic variant of CD16 to the Fc region of IgG1 (F/F allele). [14]
Jan 21The PIII SOPHIA RCT demonstrated improved progression free survival (n=536; 5.8 vs 4.9 months; HR 0.76; 95% CI, 0.59-0.98; P = 0.03) and improved overall survival (21.6 vs 19.8 months; 0.89; 0.69-1.13; P = 0.33) with margetuximab + chemotherapy vs trastuzumab + chemotherapy [13].
Nov 20Based on the current accrual rate of OS events in the SOPHIA study, MacroGenics now anticipates accrual of the 385th OS event, which triggers the final OS analysis, in H2 2021 [11].
Oct 19MacroGenics announce positive results for margetuximab in the PIII SOPHIA trial; this interim overall survival (OS) analysis showed margetuximab, provided 21.6 months OS vs. 19.8 months for trastuzumab plus chemotherapy [8].
May 19Macrogen announce positive data from PIII SOPHIA trial. RCT (n=536) showed patients receiving margetuximab plus chemotherapy had an improved median PFS vs. patients receiving trastuzumab and chemotherapy (5.8 vs. 4.9 months); thus meeting its first primary endpoint [7].
Feb 19The manufacturer reports that the PIII trial of margetuximab in HER2-positive metastatic breast cancer has met its primary endpoint by improving progression-free survival (PFS) by more than Herceptin. 536 patients with HER2-positive metastatic breast cancer were randomised to receive either margetuximab or trastuzumab on top of a chemotherapy regimen. All patients had received Herceptin (trastuzumab) and Perjeta (pertuzumab) prior to the study. Margetuzimab is associated with a 24% risk reduction in PFS compared to Herceptin (p=0.033). Overall survival data are not yet mature [6].
Oct 18The PIII SOPHIA study (NCT02492711) is still recruiting patients. The estimated primary completion date is still Mar 20 [5].
Dec 17The PIII NCT02492711 study is still recruiting patients. The estimated primary completion date is Mar 20 [4].
Aug 16The purpose of the SOPHIA study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy [3].
Aug 16The SOPHIA study is recruiting pts. Collection of co-primary endpoints (overall survival and progression-free survival) is expected to complete Jul 17 [3].
Jul 15MacroGenics initiates the PIII SOPHIA trial to evaluate margetuximab plus chemotherapy compared with standard of care in third-line, HER2-positive metastatic breast cancer (NCT02492711). The pivotal, randomised, open-label trial is intended to enrol 530 patients. Enrolment has begun in the US, Germany, Portugal and Spain, and is expected to extend to additional countries [2].
MargenzaHER-2 positive gastric and gastroesophageal junction (GEJ) cancer
Information
Margenza
Licence extension / variation
MacroGenics
MacroGenics
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
Monoclonal antibody that targets the HER2 oncoprotein
Gastric cancer is the fifth most common cancer in the world and the third leading cause of cancer death in both sexes worldwide (723,000 deaths, 9.8% of the total). The highest estimated mortality rates are in Eastern Asia. In 2008 4,923 new diagnoses of gastric cancer were made in the UK [2]. Five-year survival is low, 5-20% [1].
HER-2 positive gastric and gastroesophageal junction (GEJ) cancer
Intravenous