LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial

P. Nathan; R. Dummer; G.V. Long; P.A. Ascierto; H.A. Tawbi; C. Robert; P. Rutkowski; O. Leonov; C. Dutriaux; M. Mandala'; P. Lorigan; P.F. Ferrucci; K.T. Flaherty; J.C. Brase; S. Green; T. Haas; A. Masood; E. Gasal; A. Ribas; D. Schadendorf

doi:10.1016/j.annonc.2020.08.2273

LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial

P. Nathan, R. Dummer, G.V. Long, P.A. Ascierto, H.A. Tawbi, C. Robert, P. Rutkowski, O. Leonov, C. Dutriaux, M. Mandala', P. Lorigan, P.F. Ferrucci, K.T. Flaherty, J.C. Brase, S. Green, T. Haas, A. Masood, E. Gasal, A. Ribas, D. Schadendorf

Division of Cancer Sciences (L5)

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Abstract

Background: Treatment (tx) with immune checkpoint inhibitors + targeted therapy may induce durable and deeper responses in a higher proportion of pts. Results from the safety run-in (part 1) and biomarker cohort (part 2) of COMBI-i (NCT02967692) have been previously reported. Part 3 is a global, placebo (PBO)-controlled, double-blind, Phase III study evaluating the anti -PD-1 antibody Sparta + Dab and Tram in pts with previously untreated BRAF V600 -mutant unresectable or metastatic melanoma. Here we report the primary analysis for part 3 of COMBI-i. Methods: Pts were randomized 1:1 to receive Sparta 400 mg IV Q4W + Dab 150 mg orally BID + Tram 2 mg orally QD vs PBO-DabTram. The statistical plan ensured 80% power assuming a 5-month tx delay. The primary endpoint is investigator-assessed progression-free survival (PFS) using RECIST 1.1; significance threshold was P

Original language	English
Pages (from-to)	S1172
Journal	Annals of Oncology
Volume	31
DOIs	https://doi.org/10.1016/j.annonc.2020.08.2273
Publication status	Published - 1 Sept 2020

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Nathan, P., Dummer, R., Long, G. V., Ascierto, P. A., Tawbi, H. A., Robert, C., Rutkowski, P., Leonov, O., Dutriaux, C., Mandala', M., Lorigan, P., Ferrucci, P. F., Flaherty, K. T., Brase, J. C., Green, S., Haas, T., Masood, A., Gasal, E., Ribas, A., & Schadendorf, D. (2020). LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial. Annals of Oncology, 31, S1172. https://doi.org/10.1016/j.annonc.2020.08.2273

@article{e07b14bd9f184339af3e365e650043c4,

title = "LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial",

abstract = "Background: Treatment (tx) with immune checkpoint inhibitors + targeted therapy may induce durable and deeper responses in a higher proportion of pts. Results from the safety run-in (part 1) and biomarker cohort (part 2) of COMBI-i (NCT02967692) have been previously reported. Part 3 is a global, placebo (PBO)-controlled, double-blind, Phase III study evaluating the anti -PD-1 antibody Sparta + Dab and Tram in pts with previously untreated BRAF V600 -mutant unresectable or metastatic melanoma. Here we report the primary analysis for part 3 of COMBI-i. Methods: Pts were randomized 1:1 to receive Sparta 400 mg IV Q4W + Dab 150 mg orally BID + Tram 2 mg orally QD vs PBO-DabTram. The statistical plan ensured 80% power assuming a 5-month tx delay. The primary endpoint is investigator-assessed progression-free survival (PFS) using RECIST 1.1; significance threshold was P ",

author = "P. Nathan and R. Dummer and G.V. Long and P.A. Ascierto and H.A. Tawbi and C. Robert and P. Rutkowski and O. Leonov and C. Dutriaux and M. Mandala' and P. Lorigan and P.F. Ferrucci and K.T. Flaherty and J.C. Brase and S. Green and T. Haas and A. Masood and E. Gasal and A. Ribas and D. Schadendorf",

year = "2020",

month = sep,

day = "1",

doi = "10.1016/j.annonc.2020.08.2273",

language = "English",

volume = "31",

pages = "S1172",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Elsevier BV",

}

Nathan, P, Dummer, R, Long, GV, Ascierto, PA, Tawbi, HA, Robert, C, Rutkowski, P, Leonov, O, Dutriaux, C, Mandala', M, Lorigan, P, Ferrucci, PF, Flaherty, KT, Brase, JC, Green, S, Haas, T, Masood, A, Gasal, E, Ribas, A & Schadendorf, D 2020, 'LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial', Annals of Oncology, vol. 31, pp. S1172. https://doi.org/10.1016/j.annonc.2020.08.2273

LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial. / Nathan, P.; Dummer, R.; Long, G.V. et al.
In: Annals of Oncology, Vol. 31, 01.09.2020, p. S1172.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial

AU - Nathan, P.

AU - Dummer, R.

AU - Long, G.V.

AU - Ascierto, P.A.

AU - Tawbi, H.A.

AU - Robert, C.

AU - Rutkowski, P.

AU - Leonov, O.

AU - Dutriaux, C.

AU - Mandala', M.

AU - Lorigan, P.

AU - Ferrucci, P.F.

AU - Flaherty, K.T.

AU - Brase, J.C.

AU - Green, S.

AU - Haas, T.

AU - Masood, A.

AU - Gasal, E.

AU - Ribas, A.

AU - Schadendorf, D.

PY - 2020/9/1

Y1 - 2020/9/1

N2 - Background: Treatment (tx) with immune checkpoint inhibitors + targeted therapy may induce durable and deeper responses in a higher proportion of pts. Results from the safety run-in (part 1) and biomarker cohort (part 2) of COMBI-i (NCT02967692) have been previously reported. Part 3 is a global, placebo (PBO)-controlled, double-blind, Phase III study evaluating the anti -PD-1 antibody Sparta + Dab and Tram in pts with previously untreated BRAF V600 -mutant unresectable or metastatic melanoma. Here we report the primary analysis for part 3 of COMBI-i. Methods: Pts were randomized 1:1 to receive Sparta 400 mg IV Q4W + Dab 150 mg orally BID + Tram 2 mg orally QD vs PBO-DabTram. The statistical plan ensured 80% power assuming a 5-month tx delay. The primary endpoint is investigator-assessed progression-free survival (PFS) using RECIST 1.1; significance threshold was P

AB - Background: Treatment (tx) with immune checkpoint inhibitors + targeted therapy may induce durable and deeper responses in a higher proportion of pts. Results from the safety run-in (part 1) and biomarker cohort (part 2) of COMBI-i (NCT02967692) have been previously reported. Part 3 is a global, placebo (PBO)-controlled, double-blind, Phase III study evaluating the anti -PD-1 antibody Sparta + Dab and Tram in pts with previously untreated BRAF V600 -mutant unresectable or metastatic melanoma. Here we report the primary analysis for part 3 of COMBI-i. Methods: Pts were randomized 1:1 to receive Sparta 400 mg IV Q4W + Dab 150 mg orally BID + Tram 2 mg orally QD vs PBO-DabTram. The statistical plan ensured 80% power assuming a 5-month tx delay. The primary endpoint is investigator-assessed progression-free survival (PFS) using RECIST 1.1; significance threshold was P

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U2 - 10.1016/j.annonc.2020.08.2273

DO - 10.1016/j.annonc.2020.08.2273

M3 - Article

SN - 0923-7534

VL - 31

SP - S1172

JO - Annals of Oncology

JF - Annals of Oncology

ER -

Nathan P, Dummer R, Long GV, Ascierto PA, Tawbi HA, Robert C et al. LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial. Annals of Oncology. 2020 Sept 1;31:S1172. doi: 10.1016/j.annonc.2020.08.2273

LBA43 Spartalizumab plus dabrafenib and trametinib (Sparta-DabTram) in patients (pts) with previously untreated BRAF V600–mutant unresectable or metastatic melanoma: Results from the randomized part 3 of the phase III COMBI-i trial

Abstract

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