abbv-621 in previously treated solid and hematologic ... · abbv-621 is an investigational drug...

Venetoclax is being codeveloped by AbbVie and Genentech, a member of the Roche Group. AML, acute myeloid leukemia; CRC, colorectal cancer; DLT, dose limiting toxicity; ECOG, Eastern Cooperative Oncology Group; IV, intravenously; MTD, maximum tolerated dose; NHL, non-hodgkin lymphoma; ORR, objective response rate; PS, performance score; QTcF, QT interval measurement correct by Fridericia’s formula; R/R, relapsed or refractory; RECIST, response evaluation criteria in solid tumors; RP2D, recommended phase 2 dose. https://clinicaltrials.gov/ct2/show/NCT03082209. (accessed August 2017) Phase 1 (M15-913): ABBV-621 in Previously Treated Solid and Hematologic Malignancies Venetoclax is being investigated for indications that have not been approved by Regulatory Agencies. Safety and Eﬃcacy have not been established in unapproved indications. ©2017 AbbVie Inc. North Chicago, IL 60064 A14543624 May 2017 Printed in U.S.A. CRC Additional solid tumor^ AML* NHL* Dose Escalation Dose Expansion Key Inclusion Criteria • R/R Solid tumor, AML or NHL • ≥1 prior systemic therapy • Solid tumors only: Measurable disease per RECIST 1.1 • ECOG PS 0-2 • Adequate hematologic, renal and hepatic function Key Exclusion Criteria • History of brain metastases • History of cirrhosis Endpoints Primary: MTD, RP2D, PK, ORR Secondary: DLT, QTcF change from baseline Patients with solid tumors Phase 1 R/R Solid Tumors Hematologic Malignancies (N = 92)* *Estimated enrollment * Planned early combinations with venetoclax; ^Solid tumor type to be determined based on emerging results from clinical/preclinical data. ABBV-621 is an investigational drug that is not approved by the FDA. Safety and eﬃcacy have not been established. To learn more about these studies, please visit https://ClinicalTrials.gov or email [email protected]

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Page 1: ABBV-621 in Previously Treated Solid and Hematologic ... · ABBV-621 is an investigational drug that is not approved by the FDA. Safety and efficacy have not been established. To

Venetoclax is being codeveloped by AbbVie and Genentech, a member of the Roche Group.

AML, acute myeloid leukemia; CRC, colorectal cancer; DLT, dose limiting toxicity; ECOG, Eastern Cooperative Oncology Group; IV, intravenously; MTD, maximum tolerated dose; NHL, non-hodgkin lymphoma; ORR, objective response rate; PS, performance score; QTcF, QT interval measurement correct by Fridericia’s formula; R/R, relapsed or refractory; RECIST, response evaluation criteria in solid tumors; RP2D, recommended phase 2 dose. https://clinicaltrials.gov/ct2/show/NCT03082209. (accessed August 2017)

Phase 1 (M15-913): ABBV-621 in Previously Treated Solid and Hematologic Malignancies

Venetoclax is being investigated for indications that have not been approved by Regulatory Agencies. Safety and Efficacy have not been established in unapproved indications.

CRCAdditional solid tumor^

AML*NHL*

Dose Escalation Dose Expansion

Key Inclusion Criteria

• R/R Solid tumor, AML or NHL• ≥1 prior systemic therapy• Solid tumors only: Measurable disease per RECIST 1.1• ECOG PS 0-2• Adequate hematologic, renal and hepatic function

Key Exclusion Criteria

• History of brain metastases• History of cirrhosis

Endpoints

Primary: MTD, RP2D, PK, ORRSecondary: DLT, QTcF change from baseline

Patients with solid tumors

Phase 1R/R Solid Tumors

Hematologic Malignancies

(N = 92)*

*Estimated enrollment * Planned early combinations with venetoclax; ^Solid tumor type to be

determined based on emerging results from clinical/preclinical data.

ABBV-621 is an investigational drug that is not approved by the FDA. Safety and efficacy have not been established.

To learn more about these studies, please visit https://ClinicalTrials.gov or email [email protected]