Clinical Responses of Oncolytic Coxsackievirus A21 (V937) in Patients With Unresectable Melanoma.

Andtbacka Robert H I; Brendan Curti; Daniels Gregory A; Sigrun Hallmeyer; Whitman Eric D; Jose Lutzky; Spitler Lynn E; Karl Zhou; Bommareddy Praveen K; Mark Grose; Meihua Wang; Cai Wu; Kaufman Howard L

Clinical Responses of Oncolytic Coxsackievirus A21 (V937) in Patients With Unresectable Melanoma.

Andtbacka Robert H I
, Brendan Curti
, Daniels Gregory A
, Sigrun Hallmeyer
, Whitman Eric D
, Jose Lutzky
, Spitler Lynn E
, Karl Zhou
, Bommareddy Praveen K
, Mark Grose
, Meihua Wang
, Cai Wu
, Kaufman Howard L

Research output: Contribution to journal › Article

Abstract

PURPOSE: We evaluated the activity of intratumoral Coxsackievirus A21 (V937) in 57 patients with unresectable stage IIIC or IV melanoma.

PATIENTS AND METHODS: In this multicenter, open-label, phase II study, patients received up to a total V937 dose of 3 × 10

RESULTS: The primary efficacy end point, 6-month PFS rate per irRECIST, was 38.6% (95% CI, 26.0 to 52.4). Durable response rate (partial or complete response for ≥ 6 months) was 21.1% per irRECIST. Best overall response rate (complete plus partial response) was 38.6% (unconfirmed) and 28.1% (confirmed) per irRECIST. Regression of melanoma was observed in noninjected lesions. Based on Kaplan-Meier estimation, 12-month PFS was 32.9% (95% CI, 19.5 to 46.9) per irRECIST and 12-month overall survival was 75.4% (95% CI, 62.1 to 84.7). No treatment-related grade ≥ 3 adverse events occurred. Viral RNA was detected in serum within 30 minutes of administration. Neutralizing antibody titers increased to > 1:16 in all patients after day 22, without effect on clinical or immunologic response.

CONCLUSION: V937 was well tolerated and warrants further investigation for treatment of patients with unresectable melanoma. Studies of combination approaches with V937 and immune checkpoint inhibitors are ongoing.

Original language	Undefined/Unknown
Journal	Articles, Abstracts, and Reports
State	Published - Aug 31 2021

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http://digitalcommons.psjhealth.org/publications/5215

Cite this

@article{771117ed381a414d92d8c50d1352c2ec,

title = "Clinical Responses of Oncolytic Coxsackievirus A21 (V937) in Patients With Unresectable Melanoma.",

abstract = "PURPOSE: We evaluated the activity of intratumoral Coxsackievirus A21 (V937) in 57 patients with unresectable stage IIIC or IV melanoma. PATIENTS AND METHODS: In this multicenter, open-label, phase II study, patients received up to a total V937 dose of 3 {\texttimes} 10 RESULTS: The primary efficacy end point, 6-month PFS rate per irRECIST, was 38.6\% (95\% CI, 26.0 to 52.4). Durable response rate (partial or complete response for ≥ 6 months) was 21.1\% per irRECIST. Best overall response rate (complete plus partial response) was 38.6\% (unconfirmed) and 28.1\% (confirmed) per irRECIST. Regression of melanoma was observed in noninjected lesions. Based on Kaplan-Meier estimation, 12-month PFS was 32.9\% (95\% CI, 19.5 to 46.9) per irRECIST and 12-month overall survival was 75.4\% (95\% CI, 62.1 to 84.7). No treatment-related grade ≥ 3 adverse events occurred. Viral RNA was detected in serum within 30 minutes of administration. Neutralizing antibody titers increased to > 1:16 in all patients after day 22, without effect on clinical or immunologic response. CONCLUSION: V937 was well tolerated and warrants further investigation for treatment of patients with unresectable melanoma. Studies of combination approaches with V937 and immune checkpoint inhibitors are ongoing.",

author = "\{Robert H I\}, Andtbacka and Brendan Curti and \{Gregory A\}, Daniels and Sigrun Hallmeyer and \{Eric D\}, Whitman and Jose Lutzky and \{Lynn E\}, Spitler and Karl Zhou and \{Praveen K\}, Bommareddy and Mark Grose and Meihua Wang and Cai Wu and \{Howard L\}, Kaufman",

year = "2021",

month = aug,

day = "31",

language = "Undefined/Unknown",

journal = "Articles, Abstracts, and Reports",

}

TY - JOUR

T1 - Clinical Responses of Oncolytic Coxsackievirus A21 (V937) in Patients With Unresectable Melanoma.

AU - Robert H I, Andtbacka

AU - Curti, Brendan

AU - Gregory A, Daniels

AU - Hallmeyer, Sigrun

AU - Eric D, Whitman

AU - Lutzky, Jose

AU - Lynn E, Spitler

AU - Zhou, Karl

AU - Praveen K, Bommareddy

AU - Grose, Mark

AU - Wang, Meihua

AU - Wu, Cai

AU - Howard L, Kaufman

PY - 2021/8/31

Y1 - 2021/8/31

N2 - PURPOSE: We evaluated the activity of intratumoral Coxsackievirus A21 (V937) in 57 patients with unresectable stage IIIC or IV melanoma. PATIENTS AND METHODS: In this multicenter, open-label, phase II study, patients received up to a total V937 dose of 3 × 10 RESULTS: The primary efficacy end point, 6-month PFS rate per irRECIST, was 38.6% (95% CI, 26.0 to 52.4). Durable response rate (partial or complete response for ≥ 6 months) was 21.1% per irRECIST. Best overall response rate (complete plus partial response) was 38.6% (unconfirmed) and 28.1% (confirmed) per irRECIST. Regression of melanoma was observed in noninjected lesions. Based on Kaplan-Meier estimation, 12-month PFS was 32.9% (95% CI, 19.5 to 46.9) per irRECIST and 12-month overall survival was 75.4% (95% CI, 62.1 to 84.7). No treatment-related grade ≥ 3 adverse events occurred. Viral RNA was detected in serum within 30 minutes of administration. Neutralizing antibody titers increased to > 1:16 in all patients after day 22, without effect on clinical or immunologic response. CONCLUSION: V937 was well tolerated and warrants further investigation for treatment of patients with unresectable melanoma. Studies of combination approaches with V937 and immune checkpoint inhibitors are ongoing.

AB - PURPOSE: We evaluated the activity of intratumoral Coxsackievirus A21 (V937) in 57 patients with unresectable stage IIIC or IV melanoma. PATIENTS AND METHODS: In this multicenter, open-label, phase II study, patients received up to a total V937 dose of 3 × 10 RESULTS: The primary efficacy end point, 6-month PFS rate per irRECIST, was 38.6% (95% CI, 26.0 to 52.4). Durable response rate (partial or complete response for ≥ 6 months) was 21.1% per irRECIST. Best overall response rate (complete plus partial response) was 38.6% (unconfirmed) and 28.1% (confirmed) per irRECIST. Regression of melanoma was observed in noninjected lesions. Based on Kaplan-Meier estimation, 12-month PFS was 32.9% (95% CI, 19.5 to 46.9) per irRECIST and 12-month overall survival was 75.4% (95% CI, 62.1 to 84.7). No treatment-related grade ≥ 3 adverse events occurred. Viral RNA was detected in serum within 30 minutes of administration. Neutralizing antibody titers increased to > 1:16 in all patients after day 22, without effect on clinical or immunologic response. CONCLUSION: V937 was well tolerated and warrants further investigation for treatment of patients with unresectable melanoma. Studies of combination approaches with V937 and immune checkpoint inhibitors are ongoing.

M3 - Article

JO - Articles, Abstracts, and Reports

JF - Articles, Abstracts, and Reports

ER -