- Encouraging antitumor exercise demonstrated with vobra duo as measured by 6-month landmark rPFS price and ORR
- Sufferers remained on vobra duo by way of a median of 6 doses (ranging as much as 12), representing an extension of therapy period as in comparison with Section 1 mCRPC dose enlargement cohort
- Firm expects to have mature median rPFS no later than early 2025
- MacroGenics to host an investor name to overview key information offered at ESMO and supply a basic company replace on Monday, September 16, 2024, at 8:00 a.m. ET
ROCKVILLE, MD, Sept. 15, 2024 (GLOBE NEWSWIRE) — MacroGenics, Inc. MGNX, a biopharmaceutical firm targeted on discovering, growing, manufacturing and commercializing revolutionary antibody-based therapeutics for the therapy of most cancers, as we speak offered up to date efficacy and security outcomes from the TAMARACK Section 2 research of vobramitamab duocarmazine (vobra duo), an antibody-drug conjugate (ADC) that targets B7-H3, for sufferers with metastatic castration-resistant prostate most cancers (mCRPC). The info had been featured in a poster presentation on the European Society for Medical Oncology (ESMO) Congress, going down in Barcelona, Spain from September 13-17, 2024.
“A key motive for conducting the TAMARACK research was to check the speculation that we might enhance upon the period of vobra duo therapy noticed within the Section 1 research by decreasing the beginning dose from 3.0 mg/kg to both 2.0 or 2.7 mg/kg and growing the dosing interval from each three weeks to each 4 weeks. In doing so, our goal was to enhance security and tolerability, prolong the therapy period and obtain improved rPFS as in comparison with the lead to our Section 1 mCRPC dose enlargement cohort,” stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We imagine that these newest outcomes from TAMARACK proceed to show that vobra duo is an lively drug in prostate most cancers. Finally, our path ahead for the molecule will depend upon the ultimate security and efficacy information, together with mature median rPFS, which we count on to have in hand no later than early 2025. We count on to make choices about potential future growth within the context of a aggressive therapy panorama evaluation, useful resource allocation throughout our scientific portfolio and potential partnering alternatives for vobra duo.”
TAMARACK Examine Demographics
The summary submitted to ESMO was based mostly on an information cut-off as of April 12, 2024; up to date information based mostly on a closing date of July 9, 2024, are included under and are reported within the Firm’s poster presentation at ESMO.
The TAMARACK trial enrolled a complete of 181 individuals, with 176 individuals receiving at the very least one dose of vobra duo at both 2.0 mg/kg q4W (n=90) or 2.7 mg/kg q4W (n=86). As of the info closing date, 23 and 16 individuals remained on therapy within the 2.0 mg/kg and a pair of.7 mg/kg cohorts, respectively. Whereas mCRPC research individuals are now not being dosed within the research, individuals proceed to be monitored for hostile occasions, illness development, and survival.
Baseline Traits:
- Enrolled research individuals had a median age of 70 years (vary, 35-89).
- 88 Examine individuals (48.6%) had an ECOG efficiency standing of 1 or 2.
- 30 Examine individuals (16.6%) had visceral illness at baseline, with liver or lung illness in 25 individuals (13.8%).
- 81 Examine individuals (44.8%) had measurable illness at baseline, and 97 (53.6%) had obtained prior taxane.
- Each therapy arms had been well-balanced throughout most baseline traits, together with prior use of taxanes, androgen receptor axis-targeted (ARAT) therapy, poly-ADP ribose polymerase (PARP) therapy, and baseline PSA.
TAMARACK Efficacy Outcomes as of July 9, 2024 Reduce-off Date
General, the Firm believes that the outcomes up to now from the TAMARACK research point out antitumor exercise related to vobra duo in mCRPC as demonstrated by the protocol-specified major endpoint of landmark 6-month radiographic progression-free survival (rPFS) price, in addition to different measures of tumor response.
- Within the intent-to-treat (ITT) inhabitants, 6-month rPFS price was 69% for the two.0 mg/kg arm (95% CI, 57-79) and 70% for the two.7 mg/kg arm (95% CI, 58-79).
- Landmark 6-month rPFS charges had been constant throughout taxane-naïve research individuals (starting from 66-82%) and taxane pre-treated research individuals (starting from 60-73%), no matter therapy arm.
- Though immature, with solely 65 PFS occasions (35.9%) as of the info cut-off, median rPFS was roughly 8.5 months for the two.0 mg/kg cohort (95% CI, 7.2-11.2) and seven.5 months for the two.7 mg/kg cohort (95% CI, 7.2-10.6). As a result of these outcomes had been immature as of the cutoff date, they’re prone to change as further occasions accrue.
Tumor response charges
- Out of 45 RECIST-response evaluable sufferers within the 2.0 mg/kg arm, the confirmed goal response price (ORR) was 20.0% (n=9) and the unconfirmed ORR was 26.7% (n=12).
- Out of 32 RECIST-response evaluable sufferers within the 2.7 mg/kg arm, the confirmed ORR was 40.6% (n=13) and the unconfirmed ORR was 46.9% (n=15).
- Confirmed ORR was comparable between taxane-naïve research individuals (26.7%, n=12/45) and taxane pre-treated research individuals (17.5%, n=11/63), no matter therapy arm.
- Tumor responses didn’t seem to correlate with baseline B7-H3 expression based mostly on archival tissue samples of blended age.
TAMARACK Security Outcomes as of July 9, 2024 Reduce-off Date
General abstract of hostile occasions (AEs)
- Within the 2.0 mg/kg cohort, 65.6% of research individuals (n=59) skilled a Grade ≥3 treatment-emergent AE (TEAE); this cohort had a discontinuation price of 25.6% (n=23) and a dose discount price of fifty.0% (n=45) attributable to TEAEs.
- Within the 2.7 mg/kg cohort, 62.8% of research individuals (n=54) skilled a Grade ≥3 TEAE; this cohort had a discontinuation price of 38.4% (n=33) and a dose discount price of 54.7% (n=47) attributable to TEAEs.
- The most typical (occurring in ≥20% of research individuals) all-grade TEAEs had been: asthenia, edema peripheral, decreased urge for food, nausea, pleural effusion, diarrhea, fatigue, constipation, anemia, palmar-plantar erythrodysesthesia (PPE, or hand-foot syndrome), neutropenia, and stomatitis. Nearly all of TEAEs with a ≥10% incidence price in both therapy arm was restricted to Grade 1/2 occasions.
- Charges of pleural effusion, pericardial effusion, and PPE for each the two.0 mg/kg cohort (28.8%, 13.3%, 18.9%, respectively) and the two.7 mg/kg cohort (44.2%, 17.5%, 28%, respectively) decreased in comparison with the Section 1 mCRPC dose enlargement cohort (48.8%, 17.1%, 46.3%, respectively), regardless of an elevated median variety of doses of vobra duo administered on TAMARACK.
- Eight deadly treatment-related AEs as assessed by the treating doctor: 5 within the 2.0 mg/kg cohort and three within the 2.7mg/kg cohort. These embrace three occasions of pneumonitis, and one occasion every of cardiac failure, stress cardiomyopathy, ventricular fibrillation, pleural effusion, and gastrointestinal hemorrhage.
- Charges of treatment-related AEs (together with all grades and Grade ≥3) and treatment-related extreme AEs had been related between taxane-naïve and taxane pre-treated research individuals.
Tolerability findings
- Within the 2.0 mg/kg cohort, 25.6% of research individuals (n=23) remained on research drug as of July 9, 2024. Examine individuals obtained a median variety of 6 doses (vary, 1-11), with a median dose depth (calculated as a share of the whole deliberate dose that was administered) of 92.6% (vary, 64.2-106.1%).
- Within the 2.7 mg/kg cohort, 18.6% of research individuals (n=16) remained on research drug as of the info closing date. Examine individuals obtained a median variety of 6 doses (vary, 1-12), with a median dose depth of 81.7% (vary, 40.5-104.3%).
- Taxane-naïve research individuals skilled greater charges of dose reductions attributable to TEAEs (62.7%) and dose interruptions attributable to TEAEs (70.7%) in comparison with taxane pre-treated research individuals (44.6% and 43.6%, respectively).
ESMO Poster Presentation
Title: TAMARACK: Randomized Section 2 trial of the B7-H3 concentrating on antibody drug conjugate (ADC) vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate most cancers (mCRPC)
Presenter / Lead Writer: Johann de Bono, M.D., M.Sc., Ph.D., FRCP, FMedSci, Division of Scientific Research, Royal Marsden Hospital Institute of Most cancers Analysis, Sutton, UK
Presentation ID: 1654P
Session Date: Sunday, September 15, 2024
Poster Show Time: 9:00 a.m. – 5:00 p.m. CEST
The poster presentation is obtainable for obtain beneath “Occasions & Displays” within the Investor Relations part of MacroGenics’ web site at http://ir.macrogenics.com/events.cfm.
Convention Name
The Firm will host a convention name to debate the TAMARACK poster information and supply a basic company replace on Monday, September 16, 2024, at 8:00am ET. The decision might be led by Scott Koenig, M.D., Ph.D., President and Chief Govt Officer; Stephen Eck, M.D., Ph.D., Senior Vice President – Chief Medical Officer; and Jim Karrels, Senior Vice President – Chief Monetary Officer.
To take part through phone, please register upfront at this link. Upon registration, all phone individuals will obtain a affirmation electronic mail detailing be a part of the convention name, together with the dial-in quantity together with a novel passcode and registrant ID that can be utilized to entry the decision. The listen-only webcast of the convention name might be accessed beneath “Occasions & Displays” within the Investor Relations part of the Firm’s web site at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast might be obtainable shortly after the conclusion of the decision and archived on the Firm’s web site for 30 days following the decision.
About Vobra Duo and the TAMARACK Examine
Vobra duo is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression throughout a number of strong tumors and a member of the B7 household of molecules concerned in immune regulation. The TAMARACK Section 2 research of vobra duo is being performed in individuals with mCRPC who had been beforehand handled with one prior androgen receptor axis-targeted remedy (ARAT). Contributors could have obtained as much as one prior taxane-containing routine, however no different chemotherapy brokers. The TAMARACK research is designed to judge vobra duo at two totally different doses: 2.0 mg/kg or 2.7 mg/kg each 4 weeks (q4W).
About MacroGenics, Inc.
MacroGenics (the Firm) is a biopharmaceutical firm targeted on discovering, growing, manufacturing and commercializing revolutionary monoclonal antibody-based therapeutics for the therapy of most cancers. The Firm generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based know-how platforms, which have applicability throughout broad therapeutic domains. The mix of MacroGenics’ know-how platforms and protein engineering experience has allowed the Firm to generate promising product candidates and enter into a number of strategic collaborations with international pharmaceutical and biotechnology corporations. For extra data, please see the Firm’s web site at www.macrogenics.com. MacroGenics and the MacroGenics brand are emblems or registered emblems of MacroGenics, Inc.
Cautionary Notice on Ahead-Wanting Statements
Any statements on this press launch about future expectations, plans and prospects for MacroGenics (“Firm”), together with statements in regards to the Firm’s technique, future operations, scientific growth of and regulatory plans for the Firm’s therapeutic candidates, anticipated timing of the discharge of ultimate security and efficacy information, together with mature median rPFS and different statements containing the phrases “topic to”, “imagine”, “anticipate”, “plan”, “count on”, “intend”, “estimate”, “potential,” “venture”, “could”, “will”, “ought to”, “would”, “might”, “can”, the negatives thereof, variations thereon and related expressions, or by discussions of technique represent forward-looking statements inside the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Change Act of 1934. Precise outcomes could differ materially from these indicated by such forward-looking statements because of numerous necessary elements, together with: dangers that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or every other product candidate’s income, bills and prices will not be as anticipated, dangers regarding TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or every other product candidate’s market acceptance, competitors, reimbursement and regulatory actions; future information updates, particularly timing and outcomes of mature median radiographic progression-free survival, different efficacy and security information with respect to vobramitamab duocarmazine; our capacity to offer manufacturing providers to our prospects; the uncertainties inherent within the initiation and enrollment of future scientific trials; the provision of financing to fund the inner growth of our product candidates; expectations of increasing ongoing scientific trials; availability and timing of information from ongoing scientific trials; expectations for the timing and steps required within the regulatory overview course of; expectations for regulatory approvals; expectations of future milestone funds; the affect of aggressive merchandise; our capacity to enter into agreements with strategic companions and different issues that would have an effect on the provision or business potential of the Firm’s product candidates; enterprise, financial or political disruptions attributable to catastrophes or different occasions, together with pure disasters, terrorist assaults, civil unrest and precise or threatened armed battle, or public well being crises; prices of litigation and the failure to efficiently defend lawsuits and different claims towards us; and different dangers described within the Firm’s filings with the Securities and Change Fee. As well as, the forward-looking statements included on this press launch signify the Firm’s views solely as of the date hereof. The Firm anticipates that subsequent occasions and developments will trigger the Firm’s views to vary. Nonetheless, whereas the Firm could elect to replace these forward-looking statements sooner or later sooner or later, the Firm particularly disclaims any obligation to take action, besides as could also be required by regulation. These forward-looking statements shouldn’t be relied upon as representing the Firm’s views as of any date subsequent to the date hereof.
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CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 [email protected]
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