MACROGENICS, INC. Developing
Breakthrough Biologics,
Life-changing Medicines®
Phase 2 Interim Data
May 9, 2024 (Data Cut-off: April 12, 2024)
Legal Notices
The information in this slide deck is current as of May 9, 2024, unless otherwise noted, and is qualified in its entirety by reference to MacroGenics' Annual, Quarterly and Current Reports filed with the SEC. MacroGenics undertakes no obligation to update any of the information herein.
Cautionary Note on Forward-Looking Statements
Any statements in this slide deck about future expectations, plans and prospects for MacroGenics ("Company"), including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, including initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from MARGENZA and the Company's product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company's ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "potential," "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate's revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate's market acceptance, competition, reimbursement and regulatory actions; future data updates, especially with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises such as the novel coronavirus (referred to as COVID-19 pandemic); and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward- looking statements included in this slide deck represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
Trademarks
DART, TRIDENT, MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc. All third-party trademarks used herein are registered trademarks of their respective owners.
Investigational Agents
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.
2 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
TAMARACK mCRPC Phase 2 Study Design Summary(TAMARACK)
Key Eligibility Criteria:
Patients Enrolled N=91
• mCRPC | Experimental Arm A | |
• One prior ARAT | Vobramitamab duocarmazine | |
• Up to one prior docetaxel-containing | 2.0 mg/kg Q4W | |
regimen(a) | Primary Endpoint: | |
• ≤ 3 Prior lines of therapy for mCRPC | rPFS | |
R | Key Secondary | |
1:1 | Endpoints: | |
Patients Enrolled N=90 | ||
AEs, PSA outcomes, ORR, | ||
Stratification Factors: | DoR, SSEs, PK, ADA, nAb | |
Experimental Arm B | ||
• Visceral disease (yes vs. no) | ||
Vobramitamab duocarmazine | ||
• Prior taxane (yes vs. no) | 2.7 mg/kg Q4W | |
• Region (US/Canada vs. other) |
(a) Participants who received an additional taxane or second ARAT (androgen receptor axis-targeted agent [abiraterone, enzalutamide or apalutamide]) for <60 days as bridging therapy while awaiting lutetium-177 vipivotide tetraxetan are also eligible. Other prior chemotherapy for prostate cancer is not allowed.
mCRPC=metastatic castration-resistant prostate cancer; ORR=objective response rate; PSA=prostate-specific antigen; Q4W=every 4 weeks; R=randomize; rPFS=radiographic progression-free survival.
3 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Patient Flow
249 Patients Assessed for | |||||
Eligibility | |||||
181 Patients Enrolled | |||||
(ITT Population) | |||||
176 Patients Dosed(a) | |||||
(Safety | Population) | ||||
R | |||||
Dose: 2.0 mg/kg q4W | Dose: 2.7 mg/kg q4W | ||||
(# Cycles Received: | (# Cycles Received: | ||||
Median=6, Range 1-9) | Median=5, Range 1-10) | ||||
90 Patients Randomized | 86 Patients Randomized | ||||
82 PSA Evaluable | 71 PSA Evaluable | ||||
45 with Baseline | 32 with Baseline | ||||
Target Lesions | Target Lesions |
(a) Excludes three dosed patients who were on original Androgen Receptor Axis-Targeted therapy control arm. These patients are excluded from any analyses in this presentation.
4 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Baseline Patient Characteristics of ITT Population
Vobra Duo | Vobra Duo | All | ||||
Parameter | 2.0 mg/kg q4W | 2.7 mg/kg q4W | ||||
(n=91) | (n=90) | (n=181) | ||||
Age, years | 70.3 ± 9.03 | 69.1 ± 8.94 | 69.7 ± 8.98 | |||
Mean ± SD | ||||||
Median (range) | 71 (46-89) | 70 (35-86) | 70 (35-89) | |||
ECOG Performance Status, n (%) | ||||||
0 | 42 | (46.2) | 52 | (57.8) | 94 | (51.9) |
1 | 48 | (52.7) | 35 | (38.9) | 83 | (45.9) |
2 | 1 | (1.1) | 2 | (2.2) | 3 | (1.7) |
Baseline PSA (ng/mL) | (n=89) | (n=85) | (n=174) | |||
Mean ± SD | 180.5 | ± 542.60 | 182.6 ± 433.06 | 181.6 ± 490.74 | ||
Median (range) | 26.4 (0.8, 3447.0) | 24.7 (0.2, 2778.0) | 24.7 (0.2, 3447.0) | |||
Measurable Disease at Baseline, n (%) | 45 (49.5) | 34 (37.8) | 79 (43.6) | |||
Prior Taxane, n (%) | 52 | (57.1) | 52 | (57.8) | 104 | (57.5) |
Prior ARAT, n (%) | 46 (50.5) | 46 (51.1) | 92 (50.8) | |||
Abiraterone | ||||||
Enzalutamide | 36 (39.6) | 33 (36.7) | 69 (38.1) | |||
Apalutamide | 12 (13.2) | 10 (11.1) | 22 (12.2) | |||
Location, n (%) | ||||||
Western Europe | 66 | (72.5) | 68 | (75.6) | 134 | (74.0) |
US | 11 | (12.1) | 10 | (11.1) | 21 (11.6) | |
Eastern Europe | 8 | (8.8) | 8 | (8.9) | 16 | (8.8) |
Australia/Korea | 6 | (6.6) | 4 | (4.4) | 10 | (5.5) |
ECOG=Eastern Cooperative Oncology Group; PSA=prostate-specific antigen; ARAT=Androgen Receptor Axis-Targeted therapy.
5 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Interim Summary of Prostate-Specific Antigen (PSA) Response
PSA response evaluable population
Vobra Duo | Vobra Duo | ||
Parameter | 2.0 mg/kg q4W | 2.7 mg/kg q4W | |
(N=82) | (N=71) | ||
Any ≥50% PSA Reduction, n (%) | 41 (50.0%) | 36 (50.7%) | |
(95% CI) | (38.7 - 61.3) | (38.6 - 62.8) | |
PSA Response (Confirmed ≥50% PSA Reduction), n (%) | 36 (43.9%) | 26 (36.6%) | |
(95% CI) | (33.0 - 55.3) | (25.5 - 48.9) | |
6 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Interim Summary of Tumor Response
RECIST evaluable patients with measurable disease at baseline
Vobra Duo | Vobra Duo | ||||
Parameter | 2.0 mg/kg q4W | 2.7 mg/kg q4W | |||
(N=45) | (N=32) | ||||
Confirmed Objective Response Rate (ORR) (CR+PR), n (%) | 8 (17.8%) | 8 (25.0%) | |||
(95% CI) | (8.0 | - 32.1%) | (11.5 - 43.4%) | ||
Confirmed + Unconfirmed ORR, n (%) | 11 | (24.4%) | 14 | (43.8%) | |
Disease Control Rate (CR+PR+SD)(a), n (%) | 41 | (91.1%) | 28 | (87.5%) | |
(95% CI) | (78.8 - 97.5%) | (71.0 - 96.5%) | |||
Best Overall Response (BOR)(b), n (%) | 0 | 1 | (3.1%) | ||
Complete Response (CR) | |||||
Partial Response (PR) | 8 (17.8%) | 7 (21.9%) | |||
Stable Disease (SD) | 33 | (73.3%) | 20 | (62.5%) | |
Progressive Disease (PD) | 3 | (6.7%) | 2 | (6.3%) | |
Not Available (NA) | 1 | (2.2%) | 2 | (6.3%) | |
Confirmed + Unconfirmed BOR, n (%) | 0 | 1 | (3.1%) | ||
CR | 11 | ||||
PR | (24.4%) | 13 | (40.6%) | ||
SD | 30 | (66.7%) | 14 | (43.8%) | |
PD | 3 | (6.7%) | 2 | (6.3%) | |
NA | 1 | (2.2%) | 2 | (6.3%) |
- Disease Control Rate (DCR) = sum of confirmed responses for patients with CR, PR and SD. Protocol-defined DCR in final analysis will include patients with CR, PR, and SD for ≥ 3 months.
- Confirmed CR/PR assessed per RECIST v1.1.
7 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Best % Change from Baseline in PSA (2.0 mg/kg q4W)
PSA response evaluable population (n=82)
Summary:
• Any ≥50% PSA reduction = 41 pts. (50.0%)
• Confirmed ≥50% PSA reduction = 36 pts. (43.9%)
8 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Best % Change from Baseline in PSA (2.7 mg/kg q4W)
PSA response evaluable population (n=71)
Summary:
• Any ≥50% PSA reduction = 36 pts. (50.7%)
• Confirmed ≥50% PSA reduction = 26 pts. (36.6%)
9 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
Best % Change from Baseline in Investigator-Assessed Tumor Size (2.0 mg/kg q4W)
RECIST evaluable patients with baseline and post-baseline target lesion measurements (n=44)(a)
Summary:
• Confirmed ORR (CR+PR) = 8 (17.8%)
• Disease Control (CR+PR+SD) = 41 (91.1%)
• Confirmed + Unconfirmed ORR = 11 (24.4%)
(a) One of the 45 patients with measurable disease at baseline did not have any post-baseline tumor assessment.
10 | TAMARACK Phase 2 Interim Data • May 9, 2024 • Data Cut-off Date: April 12, 2024 | |
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MacroGenics Inc. published this content on 09 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 May 2024 20:39:38 UTC.
