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HALO 109-301

Pegvorhyaluronidase alfa with nab-paclitaxel plus gemcitabine in hyaluronan-high metastatic pancreatic adenocarcinoma (HALO 109-301)

Phase 3N = 492NCT02715804

Population
Untreated metastatic hyaluronan-high pancreatic ductal adenocarcinoma
Design
Randomised (2:1), double-blind, placebo-controlled phase 3 study of pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel and gemcitabine versus placebo plus nab-paclitaxel and gemcitabine in untreated, metastatic, hyaluronan-high pancreatic ductal adenocarcinoma. Primary end point overall survival. Registry id matched by title and enrolment (492) on ClinicalTrials.gov.
Primary endpoint
OS
Arms
  • PEGPH20 plus nab-paclitaxel and gemcitabine (experimental, n = 327): PEGPH20 3.0 ug/kg twice weekly in cycle 1 then weekly, with nab-paclitaxel 125 mg/m2 and gemcitabine 1,000 mg/m2 weekly
  • Placebo plus nab-paclitaxel and gemcitabine (control, n = 165): Placebo with nab-paclitaxel 125 mg/m2 and gemcitabine 1,000 mg/m2 weekly
People
Van Cutsem E
OSHR 1.00 (95% CI 0.80–1.27)Δ median OS−0.3 monthsPFSHR 0.97 (95% CI 0.75–1.26)Δ median PFS0 monthsΔ ORR+11 points
Show the numbers
Results reported for HALO 109-301
EndpointAnalysisPEGPH20 plus nab-paclitaxel and gemcitabinePlacebo plus nab-paclitaxel and gemcitabineEffect
OSprimaryVan 2020median 11.2 monthsmedian 11.5 monthsHR 1.00 (95% CI 0.80–1.27)P=.97492 of 494 randomised patients were in the intention-to-treat analyses (327 and 165).
PFSprimaryVan 2020median 7.1 monthsmedian 7.1 monthsHR 0.97 (95% CI 0.75–1.26)
ORRResponse independently assessed per RECIST v1.1primaryVan 202047%36%ORR ratio 1.29 (95% CI 1.03 to 1.63).
Results reported for HALO 109-301
EndpointAnalysisPEGPH20 plus nab-paclitaxel and gemcitabinePlacebo plus nab-paclitaxel and gemcitabineEffect
OSprimaryVan 2020median 11.2 monthsmedian 11.5 monthsHR 1.00 (95% CI 0.80–1.27)P=.97492 of 494 randomised patients were in the intention-to-treat analyses (327 and 165).
PFSprimaryVan 2020median 7.1 monthsmedian 7.1 monthsHR 0.97 (95% CI 0.75–1.26)
ORRResponse independently assessed per RECIST v1.1primaryVan 202047%36%ORR ratio 1.29 (95% CI 1.03 to 1.63).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS10.8–1.27
PFS0.970.75–1.26
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • PEGPH20 plus nab-paclitaxel and gemcitabine (experimental)
  • Placebo plus nab-paclitaxel and gemcitabine (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPEGPH20 plus nab-paclitaxel and gemcitabinePlacebo plus nab-paclitaxel and gemcitabine
0100.0%100.0%
764.8%65.6%
1442.0%43.0%
2225.6%26.6%
2916.6%17.4%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • PEGPH20 plus nab-paclitaxel and gemcitabine (experimental)
  • Placebo plus nab-paclitaxel and gemcitabine (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPEGPH20 plus nab-paclitaxel and gemcitabinePlacebo plus nab-paclitaxel and gemcitabine
0100.0%100.0%
467.7%67.7%
941.5%41.5%
1328.1%28.1%
1817.3%17.3%
Primary publication: Van Cutsem E, Tempero MA, Sigal D, Oh DY, Fazio N, Macarulla T, et al. Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma. J Clin Oncol. 2020;38(27):3185-3194. PubMedDOI

Appears in

Sources

  1. Van Cutsem E, Tempero MA, Sigal D, Oh DY, Fazio N, Macarulla T, et al. Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma. J Clin Oncol. 2020;38(27):3185-3194.

    PubMedDOI