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  • Final planned overall survival (OS) from OPTiM, a randomized Phase III trial of talimogene laherparepvec (T-VEC) versus GM-CSF for the treatment of unresected stage IIIB/C/IV melanoma (NCT00769704)

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Final planned overall survival (OS) from OPTiM, a randomized Phase III trial of talimogene laherparepvec (T-VEC) versus GM-CSF for the treatment of unresected stage IIIB/C/IV melanoma (NCT00769704)
  1. Robert HI Andtbacka1,
  2. Frances A Collichio2,
  3. Thomas Amatruda3,
  4. Neil Senzer4,
  5. Jason Chesney5,
  6. Keith Delman6,
  7. Lynn Spitler7,
  8. Igor Puzanov8,
  9. Sanjiv Agarwala9,
  10. Mohammed Milhem10,
  11. Kevin Harrington11,
  12. Mark Middleton12,
  13. Ai Li13,
  14. Mark Shilkrut13,
  15. Robert Coffin14 and
  16. Howard Kaufman15
  1. Aff1 grid.412722.00000000405153663Huntsman Cancer Institute Salt Lake City UT USA
  2. Aff2 grid.10698.360000000122483208The University of Carolina at Chapel Hill Chapel Hill NC USA
  3. Aff3 grid.492844.70000 0004 0434 517XMinnesota Oncology MN USA
  4. Aff4 grid.416487.80000000404554449Mary Crowley Cancer Research Center TX USA
  5. Aff5 grid.266623.50000000121131622University of Louisville Louisville KY USA
  6. Aff6 grid.189967.80000000419367398Emory University Atlanta GA USA
  7. Aff7 grid.490332.fNorthern California Melanoma Center San Francisco CA USA
  8. Aff8 grid.412807.80000000419369916Vanderbilt University Medical Center Nashville TN USA
  9. Aff9 grid.449409.4St. Luke's University Hospital & Health Network Bethlehem PA USA
  10. Aff10 grid.214572.70000000419368294University of Iowa Iowa City IA USA
  11. Aff11 grid.18886.3f0000000112714623The Institute of Cancer Research/The Royal Marsden Hospital London UK
  12. Aff12 grid.451056.30000000121163923National Institute for Health Research Biomedical Research Centre London UK
  13. Aff13 grid.417886.40000000106575612Amgen Inc Thousand Oaks CA USA
  14. Aff14 grid.417886.40000 0001 0657 5612Amgen Woburn MA USA
  15. Aff15 grid.430387.b0000000419368796Rutgers Cancer Institute of New Jersey New Brunswick NJ USA

https://doi.org/10.1186/2051-1426-2-S3-P263

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    Meeting abstracts

    Background

    T-VEC is an oncolytic immunotherapy 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, a randomized Phase III trial of T-VEC vs GM-CSF in patients with unresected melanoma with regional or distant metastases met the primary objective of an improvement in durable response rate (response lasting continuously for ≥6 months) with T-VEC versus GM-CSF (16% vs 2%, respectively; P<0.001). Most common adverse events with T-VEC were fatigue, chills, and pyrexia. No ≥grade 3 adverse events occurred in ≥3% of patients in either arm (Andtbacka et al., J Clin Oncol 2013,32[suppl]:LBA9008). At the primary analysis (PA) of secondary OS endpoint, with median follow-up of 44 (range, 32-59) months and 189 events in the T-VEC arm and 101 events in the GM-CSF arm, median (95%CI) OS was 23.3 (19.5-29.6) months for T-VEC and 18.9 (16.0-23.7) months for GM-CSF (hazard ratio [HR]=0.79; 95%CI = 0.62-1.00; P = 0.051) (Kaufman et al., J Clin Oncol 2014,32[suppl]:9008a). A planned analysis of OS at 3 years from the last randomization is presented here.

    Methods

    Eligible patients were ≥18 years old; had ECOG performance status (PS) ≤1; unresectable melanoma stage IIIB/C/IV; injectable cutaneous, subcutaneous (SC) or nodal lesions; LDH≤1.5X upper limit of normal; ≤3 visceral lesions (excluding lung), none>3 cm. Patients 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 × 14 ds q4w).

    Results

    Of 436 patients in the intent-to-treat analysis, 295 (68%) patients received T-VEC and 141 (32%) patients received GM-CSF; 57% were men; median age 63 yrs. At time of the final OS analysis with median follow-up of 49 months [range, 37-63], only 1 additional event occurred (T-VEC arm). Median (95%CI) OS was 23.3 months (95%CI = 19.5-29.6) for T-VEC and 18.9 months (16.0-23.8) for GM-CSF; HR = 0.80 (95%CI = 0.62-1.01), P = 0.06 (descriptive). Five-year survival for the T-VEC arm was 33.4% (95%CI = 27.7-39.2). T-VEC effect on OS was most pronounced in patients with stage IIIB/C/IVM1a melanoma (HR = 0.57; 95%CI = 0.41-0.81, P = 0.001 [descriptive]) and in patients with treatment-naive disease (HR = 0.52; 95%CI = 0.36-0.75, P < 0.001 [descriptive]).

    Conclusions

    With >4 years of median follow-up for survival, a persistent relevant OS effect was demonstrated with further follow-up. Long-term follow-up continues in the registry trial (NCT02173171). T-VEC represents a novel potential therapy for patients with regionally and distantly metastatic melanoma.