OPTiM: A randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma.

2013 ◽  
Vol 31 (18_suppl) ◽  
pp. LBA9008-LBA9008 ◽  
Author(s):  
Robert Hans Ingemar Andtbacka ◽  
Frances A. Collichio ◽  
Thomas Amatruda ◽  
Neil N. Senzer ◽  
Jason Chesney ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Response Rate ◽  
Objective Response ◽  
Distant Metastases ◽  
Complete Response ◽  
Stage Iiib ◽  
Phase Iii ◽  
Durable Response ◽  
Phase Iii Trial ◽  
Gm Csf

LBA9008 Background: T-VEC is an oncolytic immunotherapy (OI) derived from herpes simplex virus type-1 designed to selectively replicate within tumors and to produce GM-CSF to enhance systemic antitumor immune responses. OPTiM is a randomized, phase III trial of T-VEC or GM-CSF in patients (pts) with unresected melanoma with regional or distant metastases. We report the primary results of the first phase III study of OI. Methods: Key criteria: age ≥18 yrs; ECOG ≤1; unresectable melanoma stage IIIB/C or IV; injectable cutaneous, SC, or nodal lesions; LDH ≤1.5X upper limit of normal; ≤3 visceral lesions (excluding lung), none >3 cm. Pts were randomized 2:1 to intralesional T-VEC (initially ≤ 4 mL x106 pfu/mL then after 3 wks, ≤ 4 mL x108 pfu/mL Q2W) or SC GM-CSF (125 µg/m2qd x 14 days q28d). The primary endpoint was durable response rate (DRR): partial or complete response (CR) continuously for ≥6 mos starting within 12 mos. Responses were per modified WHO by blinded central review. A planned interim analysis of overall survival (OS; key secondary endpoint) was performed. Results: 436 pts are in the ITT set: 295 (68%) T-VEC, 141 (32%) GM-CSF. 57% were men; median age was 63 yrs. Stage distribution was: IIIB/C 30%, IVM1a 27%, IVM1b 21%, IVM1c 22%. Objective response rate with T-VEC was 26% (95% CI: 21%, 32%) with 11% CR, and with GM-CSF was 6% (95% CI: 2%, 10%) with 1% CR. DRR for T-VEC was 16% (95% CI: 12%, 21%) and 2% for GM-CSF (95% CI: 0%, 5%), p<0.0001. DRR by stage (T-VEC, GM-CSF) was IIIB/C (33%, 0%), M1a (16%, 2%), M1b (3%, 4%), and M1c (8%, 3%). Interim OS showed a trend in favor of T-VEC; HR 0.79 (95% CI: 0.61, 1.02). Most common adverse events (AEs) with T-VEC were fatigue, chills, and pyrexia. Serious AEs occurred in 26% of T-VEC and 13% of GM-CSF pts. No ≥ grade 3 AE occurred in ≥ 3% of pts in either arm. Conclusions: T-VEC demonstrated both a statistically significant improvement in DRR over GM-CSF in pts with unresectable stage IIIB-IV melanoma and a tolerable safety profile; an interim analysis showed a trend toward improved OS. T-VEC represents a novel potential tx option for melanoma with regional or distant metastases. Clinical trial information: NCT00769704.

Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma

2015 ◽  
Vol 33 (25) ◽  
pp. 2780-2788 ◽  
Author(s):  
Robert H.I. Andtbacka ◽  
Howard L. Kaufman ◽  
Frances Collichio ◽  
Thomas Amatruda ◽  
Neil Senzer ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iiib ◽  
Phase Iii ◽  
Talimogene Laherparepvec ◽  
Durable Response ◽  
Overall Response ◽  
Gm Csf ◽  
Oncolytic Immunotherapy

Purpose Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to selectively replicate within tumors and produce granulocyte macrophage colony-stimulating factor (GM-CSF) to enhance systemic antitumor immune responses. T-VEC was compared with GM-CSF in patients with unresected stage IIIB to IV melanoma in a randomized open-label phase III trial. Patients and Methods Patients with injectable melanoma that was not surgically resectable were randomly assigned at a two-to-one ratio to intralesional T-VEC or subcutaneous GM-CSF. The primary end point was durable response rate (DRR; objective response lasting continuously ≥ 6 months) per independent assessment. Key secondary end points included overall survival (OS) and overall response rate. Results Among 436 patients randomly assigned, DRR was significantly higher with T-VEC (16.3%; 95% CI, 12.1% to 20.5%) than GM-CSF (2.1%; 95% CI, 0% to 4.5%]; odds ratio, 8.9; P < .001). Overall response rate was also higher in the T-VEC arm (26.4%; 95% CI, 21.4% to 31.5% v 5.7%; 95% CI, 1.9% to 9.5%). Median OS was 23.3 months (95% CI, 19.5 to 29.6 months) with T-VEC and 18.9 months (95% CI, 16.0 to 23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P = .051). T-VEC efficacy was most pronounced in patients with stage IIIB, IIIC, or IVM1a disease and in patients with treatment-naive disease. The most common adverse events (AEs) with T-VEC were fatigue, chills, and pyrexia. The only grade 3 or 4 AE occurring in ≥ 2% of T-VEC–treated patients was cellulitis (2.1%). No fatal treatment-related AEs occurred. Conclusion T-VEC is the first oncolytic immunotherapy to demonstrate therapeutic benefit against melanoma in a phase III clinical trial. T-VEC was well tolerated and resulted in a higher DRR (P < .001) and longer median OS (P = .051), particularly in untreated patients or those with stage IIIB, IIIC, or IVM1a disease. T-VEC represents a novel potential therapy for patients with metastatic melanoma.

Progression-free survival (PFS) in unresectable melanoma patients (pts) treated with talimogene laherparepvec (T-VEC) versus granulocyte macrophage colony-stimulating factor (GM-CSF) in OPTiM.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9524-9524
Author(s):  
Mohammed M. Milhem ◽  
Kevin J. Harrington ◽  
Frances A. Collichio ◽  
Thomas Amatruda ◽  
Jason Alan Chesney ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Distant Metastases ◽  
Complete Response ◽  
Stage Iiib ◽  
Disease Stage ◽  
Treatment Benefit ◽  
Durable Response ◽  
Gm Csf ◽  
Intention To Treat ◽  
Macrophage Colony

9524 Background: T-VEC is a modified oncolytic herpes virus designed as an intralesional therapy for unresectable advanced melanoma. OPTiM was a randomized, phase 3 trial that showed improved durable response rate (DRR) with T-VEC vs GM-CSF in pts with unresectable melanoma with regional or distant metastases (16.3% vs 2.1%, p < 0.001). Treatment benefit of T-VEC on DRR and overall survival (OS) was greater in stage IIIB-IVM1a vs IVM1b-IVM1c melanoma. This is the first report of PFS for T-VEC vs GM-CSF. Methods: OPTiM included pts ≥18 yrs with unresectable stage IIIB-IV melanoma; ≥1 injectable cutaneous, subcutaneous (SC), or nodal lesion; ECOG ≤1; LDH ≤1.5 ULN; ≤3 visceral metastases (excluding lung) with none > 3 cm. Pts were randomized 2:1 to receive intralesional T-VEC or SC GM-CSF. The primary endpoint was DRR (partial or complete response continuously for ≥6 mo starting within 12 mo) and reported previously. In this post hoc analysis, PFS was evaluated overall and by disease stage. Results: This analysis included 436 pts: 295 (68%) T-VEC, 141 (32%) GM-CSF; 57% men; 63 yr median age; 57% stage IIIB-IVM1a, 43% stage IVM1b-IVM1c. In the intention to treat set, T-VEC significantly improved PFS (HR: 0.68, 95% CI: 0.54, 0.85, unstratified log-rank p < 0.001). In stage IIIB-IVM1a, PFS favored the T-VEC arm vs the GM-CSF arm (HR: 0.60, 95% CI: 0.44, 0.80, unstratified log-rank p < 0.001). No treatment difference was seen in stage IVM1b-IVM1c (HR: 0.81, 95% CI: 0.57, 1.15, unstratified log-rank p = 0.199). Overall, the 12 mo PFS rate for T-VEC was 14.4% (95% CI: 10.5, 18.8) and GM -CSF was 4.6% (95% CI: 1.6, 10.2). In stage IIIB-IVM1a, the 12 mo PFS rate for T-VEC was 19.9% (95% CI: 14.0, 26.6) and GM-CSF was 3.2% (95% CI: 0.6, 9.9). In stage IVM1b-IVM1c, the 12 mo PFS rate for T-VEC was 7.4% (95% CI: 3.5, 13.2) and GM-CSF was 8.0% (95% CI: 1.9, 20.1). Conclusions: T-VEC demonstrated an improvement in PFS vs GM-CSF, driven primarily by pts with stage IIIB-IVM1a melanoma. This is consistent with previous data showing more pronounced OS benefit with T-VEC and greater efficacy with other immunotherapies in early metastatic disease. Clinical trial information: NCT00769704.

Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpesvirus in unresectable metastatic melanoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9035-9035 ◽  
Author(s):  
N. N. Senzer ◽  
H. Kaufman ◽  
T. Amatruda ◽  
M. Nemunaitis ◽  
G. Daniels ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Metastatic Melanoma ◽  
Phase Ii ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iv ◽  
Complete Response ◽  
Phase Iii ◽  
Stage Iiic ◽  
Gm Csf

9035 Background: OncoVEXGM-CSF is a an oncolytic HSV, encoding GM-CSF . We recently completed a phase II trial involving 50 advanced melanoma patients (stage IIIc and IV) with at least one injection accessible lesion, including by ultrasound. Methods: Patients received a single IT injection of 106 pfu/ml apportioned between 10 or less injectable tumors, followed 3 wks later by 24 or less sequential injections of 108 pfu/ml every 2 wks until clinically significant disease progression, or overall or injectable lesion complete response. Response (RECIST modified to allow progression before response and biopsy of residual masses) and survival were monitored. Results: All 50 pts have been enrolled and are evaluable (Stage IIIc, n=10; IV M1a, n=16; IV M1b, n=4; IV M1c, n=20). A median of 6 injections were administered. Adverse effects were limited and generally involved transient flu-like symptoms. Both injected and uninjected regional and distant disease demonstrated response including clearly documented responses at uninjected visceral sites. The overall response rate was 26% (8 CR, 5 PR); 10 responses have been maintained for >6 months and 2 are ongoing at <6months, the longest currently being at 35 months from first dose. 93% of patients (14 of 15) with PR, CR or surgical CR remain alive. Ten additional patients had SD for >3 months. Kaplan Meier one year survival is 61% overall, 58% stage IV only, 48% for Stage IV M1c. The median OS is 16+ months. Conclusions: The 1-year survival and durable objective response rate are encouraging. Responses of distant and visceral disease provide further compelling evidence of systemic effectiveness. This, combined with a limited toxicity profile, suggests OncoVEXGM-CSF is a promising treatment for metastatic melanoma. A phase III clinical trial is planned. [Table: see text]

Preliminary results of G versus GViElC: A phase III trial of gemcitabine associated to vindesine or gemcitabine alone in elderly or poor performance patients with advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17083-17083
Author(s):  
A. Santo ◽  
G. Genestreti ◽  
A. Terzi ◽  
P. Azzoni ◽  
O. Caffo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Interim Analysis ◽  
Standard Treatment ◽  
Stage Iv ◽  
Poor Performance ◽  
Stage Iiib ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Ecog Ps ◽  
To Receive

17083 Background: Monochemotherapy with gemcitabine (GEM) or vinorelbine is considered the standard treatment in elderly or poor performance (PS) patients (pts) with advanced NSCLC. Many topics report a synergic enhancement of antitumor effect of GEM if associated to Vindesine (VDS). The aim of this study is to evaluate if GEM combined to VDS produces an advantage in terms of overall survival (OS) compared to GEM alone without enhancement of toxicity. Methods: Chemonaive pts with stage IIIB/IV NSCLC, aged ≥ 70 years with PS < 2 or aged < 70 years with PS > 2 were enrolled. Pts were randomized to receive either GEM 1200 mg/m2 day 1 and 8 every 21 days for three cycles (arm 1) or GEM 1000 mg/m2 and VDS 3 mg/m2 (max dose 5 mg) both drugs infused on day 1 and 8 every 21 days for three cycles (arm 2). Pts of both arms received other three cycles in case of responsive or stable disease. Overall survival (OS) was the primary end-point, secondary end-points were time-to-progression and toxicity. First interim analysis was planned at 120 pts enrolled. Results: From May 2002 to December 2005, 107 pts from 13 Italian institutions were enrolled. Their characteristics are: 24 stage IIIB and 83 stage IV, 79 pts with ≥ 70 years (ECOG PS 0–1) and 28 pts with < 70 years (ECOG PS > 2). In arm 1 there were enrolled 55 pts while 52 pts in arm 2: both arms were well balanced with pts characteristics. Conclusions: The enrollment of this phase III trial is ongoing: we are achieving first step for an interim analysis to assess if GEM associated to VDS produces an advantage in terms of OS compared to standard treatment as GEM in monochemotherapy without toxicity enhancement. (Supported by GIVOP: Gruppo Interdisciplinare Veronese di Oncologia Polmonare). No significant financial relationships to disclose.

OPTiM: A randomized phase III trial to evaluate the efficacy and safety of talimogene laherparepvec (T-VEC) compared with subcutaneously (sc) administered GM-CSF for the treatment (tx) of unresectable stage IIIb, IIIc, and IV melanoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS8604-TPS8604
Author(s):  
Howard Kaufman ◽  
Volker Jean Wagner ◽  
Howard Goldsweig ◽  
Bin Yao ◽  
Robert Coffin
Keyword(s):  
Stage Iiib ◽  
High Rate ◽  
Phase Iii ◽  
Fisher Exact Test ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Durable Response ◽  
Exact Test ◽  
Gm Csf ◽  
Unresectable Stage

TPS8604 Background: T-VEC (formerly OncoVEXGM-CSF) is an oncolytic HSV1 that selectively replicates in tumors. The proposed MOA includes lytic destruction of injected tumors and induction of a systemic anti-tumor immune response enhanced by local GM-CSF expression. Intratumoral T-VEC tx in a 50-patient (pt) ph II study in advanced melanoma (Stage IIIc-IVM1c) was well tolerated and achieved a high rate and duration of response, including 20% CR (Senzer et al., JCO 2009; 27: 5763-71). As immune effects may be delayed, progressive disease (PD) often occurred before response. Based on the ph II data, a randomized ph III trial of T-VEC in unresectable melanoma (the OPTiM study; clinical trials registry NCT00769704) was designed taking into account the response patterns seen with T-VEC and other immunotherapeutic agents. T-VEC is the first "armed" oncolytic agent to enter pivotal testing worldwide. Methods: OPTiM compares the efficacy and safety of intratumoral T-VEC to sc GM-CSF in 430 pts with treated or untreated unresectable Stage IIIb-IVM1c melanoma stratified by typical prognostic factors. Pts are randomized 2:1 to T-VEC (priming dose of up to 4 x 106 pfu intratumorally then 3 wks later by up to 4 x 108 pfu Q2W) or GM-CSF 125 µg/m2 qd sc x 14 days every 28 days. Key eligibility criteria are ≥ 18 yrs old, ECOG 0-1, and at least 1 injectable cutaneous, sc, or nodal tumor. The primary endpoint is durable response rate (DRR: CR or PR continuously maintained for ≥ 6 mo initiating within 12 mo of starting tx; secondary endpoints include OS. Responses are subject to independent review. Pts are treated until wk 24, even with PD. Thereafter pts are treated until clinically significant PD, CR, or for 1 yr. The study has 90% power to show a 10% difference in DRR with 2-sided Fisher Exact Test (α = 5%). Enrollment closed in July 2011 with 439 pts randomized in the US, UK, S Africa, and Canada. Interim analysis in Dec 2010 on 75 pts on study > 9 mo concluded that the study should continue. Results are expected during 2012. Conclusions: T-VEC provides a novel potential tx for melanoma. This pivotal ph III study is expected to report during 2012.

Randomized Phase II Trial Comparing Nitroglycerin Plus Vinorelbine and Cisplatin With Vinorelbine and Cisplatin Alone in Previously Untreated Stage IIIB/IV Non–Small-Cell Lung Cancer

2006 ◽  
Vol 24 (4) ◽  
pp. 688-694 ◽  
Author(s):  
Hiroyasu Yasuda ◽  
Mutsuo Yamaya ◽  
Katsutoshi Nakayama ◽  
Takahiko Sasaki ◽  
Satoru Ebihara ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Small Cell ◽  
Stage Iiib ◽  
Phase Iii ◽  
Severe Adverse Effect ◽  
Small Cell Lung ◽  
Phase Iii Trial

Purpose To investigate the efficacy and safety of nitroglycerin plus vinorelbine and cisplatin in patients with previously untreated stage IIIB/IV non–small-cell lung cancer (NSCLC) as the experimental arm for the next phase III trial. Patients and Methods One hundred twenty patients with stage IIIB/IV NSCLC were randomly assigned to vinorelbine 25 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 on day 1, with transdermally applied nitroglycerin (25 mg/patient daily for 5 days; arm A) or with placebo patch (arm B) every 3 weeks for a maximum of four cycles in a double-blind and controlled trial. Primary efficacy end points were the best confirmed response rate and time to disease progression (TTP). Results The response rate in arm A (72%; 43 of 60 patients) was significantly higher than that for patients in arm B (42%; 25 of 60 patients; P < .001). Median TTP in arm A was longer than that in arm B (327 v 185 days). No severe adverse effect was recognized for either arm. The rate of grade 1 to 2 headache in arm A (30%; 18 of 60 patients) was significantly higher than that in arm B (2%; one of 60 patients; P < .001, χ2 test). Conclusion Use of nitroglycerin combined with vinorelbine and cisplatin may improve overall response and TTP in patients with stage IIIB/IV NSCLC. The arm A regimen is being evaluated in a large phase III trial.

Gemcitabin (G) plus cisplatin (P) versus etoposid (E) plus cisplatin in advanced/metastatic non-small cell lung cancer (NSCLC): Preliminary results of a randomized monocentric study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18155-18155
Author(s):  
A. Bousahba ◽  
F. Bereksi-Reguig
Keyword(s):  
Treatment Response ◽  
Response Rate ◽  
Objective Response ◽  
Survival Rates ◽  
Complete Response ◽  
Stage Iiib ◽  
Grade 3 ◽  
Intent To Treat ◽  
Metastatic Sites ◽  
Ecog Ps

18155 Background: we performed a randomized monocentric study to compare the treatment response of two chemotherapy doublets EP versus GP. Survival rates and toxicity are the secondary endpoints. Methods: from December 2003 to October 2006, patients with non-operable stage IIIB /IV histological or cytological proven NSCLC, ECOG PS = 2, were randomized to: (A) gemcitabin 1250 mg/m2 on d 1, 8 plus cisplatin 80 mg/m2 on d1 q3w for 6 cycles or (B) cisplatin at same dose followed by etoposid 100 mg / m2 on d1, 2, 3 q3w. The sample size was estimated at 64 patients per treatment arm to provide a power of 0.80 to detect a 20% difference in response rate between the two groups at the 5% level. Results: one hundred thirteen chemonaïve patients were enrolled (A: 57, B: 56), median age 61 years (arm A) and 57.5 years (arm B), stage IIIB (42.1% A vs 41.1% B), two or more metastatic sites (34% A, 39% B), PS 1 (68.4% A, 69.6% B). 360 cycles were administered 187 (A) and 173 (B) with a median of 3 cycles per patient in each group. Two patients were excluded from analysis. One hundred one patients were evaluable for toxicity, 90 for response. 47 pts were evaluable in A and 43 pts in B with treatment response in intent to treat principle respectively: complete response (1.8% - 0%), partial responses (29.1% and 20.7%). The objective response rate was 30.9% (95% CI 18.8%-43.2%) in A, 20.7% (95% CI 9.8%-31.6%) in B, no change (36.4% and 37.7%) and progressive disease (18.2% and 22.6%). Median duration of objective response 8.2 months (A) and 8.3 months (B), median time to progression : 8.0 months (A) and 7.5 months (B). Incidences of grade 3–4 toxicities were respectively in arms A and B: nausea-vomiting (37%-12.5%), leucopenia (5.6%-14.6%), neutropenia (13%-37.5%), thrombopenia (0–2.1%), anemia (13%-6.3%). Febril neutropenia occurred in 1.9% (A) and 8.3% (B). One toxic death occurred in arm B. Conclusions: preliminary analysis indicates that GP had a more favourable toxicity profile and a higher activity is suggested for the GP regimen. The enrolment is continued. No significant financial relationships to disclose.

Patterns of durable response with intralesional talimogene laherparepvec (T-VEC): Results from a phase III trial in patients with stage IIIb-IV melanoma.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 9026-9026 ◽  
Author(s):  
Merrick I. Ross ◽  
Robert Hans Ingemar Andtbacka ◽  
Igor Puzanov ◽  
Mohammed M. Milhem ◽  
Frances A. Collichio ◽  
...  
Keyword(s):  
Stage Iiib ◽  
Phase Iii ◽  
Talimogene Laherparepvec ◽  
Durable Response ◽  
Phase Iii Trial

scholarly journals Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma

2020 ◽  
Vol 38 (33) ◽  
pp. 3937-3946
Author(s):  
Caroline Robert ◽  
Georgina V. Long ◽  
Benjamin Brady ◽  
Caroline Dutriaux ◽  
Anna Maria Di Giacomo ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Advanced Melanoma ◽  
Phase Iii ◽  
Wild Type ◽  
Double Blind ◽  
Durable Response ◽  
Term Survival ◽  
End Points

PURPOSE The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated BRAF wild-type advanced melanoma. Five-year results are presented herein. PATIENTS AND METHODS In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type BRAF melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m2 every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. RESULTS Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n = 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report. CONCLUSION Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.

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