Phase 2 Trial of Apatorsen for Metastatic Pancreatic Cancer Misses Primary Endpoint

Share this content:
Researchers evaluated whether adding apatorsen to a standard chemotherapy regimen would improve outcomes among patients with metastatic pancreatic cancer.
Researchers evaluated whether adding apatorsen to a standard chemotherapy regimen would improve outcomes among patients with metastatic pancreatic cancer.

Adding apatorsen to gemcitabine and nab-paclitaxel does not improve clinical outcomes among unselected patients with pancreatic cancer, according to research published in The Oncologist.1

Apatorsen is an oligonucleotide that targets heat shock protein 27 (Hsp27), which is associated with chemotherapy resistance. For this phase 2 randomized study (ClinicalTrials.gov Identifier: NCT01844817), researchers evaluated whether adding apatorsen to a standard chemotherapy regimen would improve outcomes among patients with metastatic pancreatic cancer, which carries a dismal prognosis of less than a year.

Of 132 enrolled patients, 66 were randomly assigned to receive gemcitabine, nab-paclitaxel, and apatorsen, or receive to gemcitabine, nab-paclitaxel, and placebo. Patients were treated until progression or intolerable toxicity.

Overall responses were similar, with an objective response rate of 18% in both groups. Overall survival (OS) and progression-free survival (PFS) rates were 2.7 and 5.3 months, respectively, in the experimental arm, vs 3.8 and 6.9 months, respectively, for the control arm. Toxicity was similar in both arms.

Among patients with high serum levels of Hsp27, the authors noted that apatorsen improved PFS (3.3 months) and OS (3.3 months) vs placebo (.9 months and 1 month, respectively).

The authors concluded that further studies of apatorsen “in unselected patients do not appear to be indicated, although the findings from this trial do hint at the possible prognostic and predictive value of serum Hsp27 that may warrant further investigation.”

Reference

  1. Ko AH, Murphy PB, Peyton JD, et al. A randomized, double‐blinded, phase II trial of gemcitabine and nab‐paclitaxel plus apatorsen or placebo in patients with metastatic pancreatic cancer: the RAINIER trial. Oncologist. 2017 Sep 21. doi: 10.1634/theoncologist.2017-0066 [Epub ahead of print]

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters