RESOLVE tested the leukaemia drug ibrutinib as a way to reprogramme the immune cells around pancreatic tumours; added to nab-paclitaxel and gemcitabine it shortened the time to progression and cut the chemotherapy patients could tolerate, with no survival gain.
RESOLVE randomised 424 patients (211 ibrutinib, 213 placebo). After a median follow-up of 25 months, median overall survival was 9.7 against 10.8 months (p 0.3225), progression-free survival was shorter with ibrutinib (5.3 against 6.0 months; p below 0.0001) and response lower (29 against 42 percent; p 0.0058); patients on ibrutinib spent less time on treatment and received lower cumulative doses of every agent. Grade 3 or worse neutropenia was 24 against 35 percent, peripheral sensory neuropathy 17 against 8 percent and anaemia 16 against 17 percent. Seven UK sites took part (Derriford Plymouth, Broomfield Chelmsford, the Christie, Southampton, Clatterbridge, the Royal Marsden Sutton and the Royal Free). The registry figure of 430 exceeds the 424 randomised in the paper by six.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
430 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Ibrutinib + nab-paclitaxel + gemcitabine | 211 | 9.7 months | - | 0.3225 | link |
| Placebo + nab-paclitaxel + gemcitabine | 213 | 10.8 months | ||||
| Progression-free survival (investigator)primary | Ibrutinib + nab-paclitaxel + gemcitabine | 211 | 5.3 months | - | <0.0001 | link |
| Placebo + nab-paclitaxel + gemcitabine | 213 | 6 months |
Shares Gemcitabine + nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma.
Shares Pancreatic cancer: the failed and stopped programmes and why, Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma.
Shares Pancreatic cancer: the failed and stopped programmes and why, Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma.
Shares Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.
Shares Pancreatic cancer: the failed and stopped programmes and why, Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Cytotoxic chemotherapy.
Shares Gemcitabine + nab-paclitaxel, Nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.
Shares Pancreatic cancer: the failed and stopped programmes and why, Gemcitabine + nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.
Shares Pancreatic cancer: the failed and stopped programmes and why, Gemcitabine + nab-paclitaxel, Metastatic pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma.