Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY3500518, AM0010, PEGylated recombinant human Interleukin-10, PEG-rHuIL-10
Pegilodecakin · 2 trials · 10 indications
Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
Serum concentration of Pegilodecakin is reported.
| Arm | Type | Description |
|---|---|---|
| Pegilodecakin + FOLFOX | EXPERIMENTAL | Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg. |
| FOLFOX | ACTIVE_COMPARATOR | FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. |
| Part A: Pegilodecakin 0.08/0.1 mg | EXPERIMENTAL | Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 0.2/0.25 mg | EXPERIMENTAL | Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 0.4/0.5 mg | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 0.8/1 mg | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 1.6/2 mg | EXPERIMENTAL | Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 3.2/4 mg | EXPERIMENTAL | Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane | EXPERIMENTAL | Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX | EXPERIMENTAL | Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part C: Pegilodecakin 0.8/1 mg + FOLFOX | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part E: Pegilodecakin 0.8/1 mg + Capecitabine | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part G: Pegilodecakin 0.8/1 mg + Pazopanib | EXPERIMENTAL | Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | EXPERIMENTAL | Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | EXPERIMENTAL | Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part I: Pegilodecakin 1.6/2 mg + Nivolumab | EXPERIMENTAL | Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part I: Pegilodecakin 0.8/1 mg + Nivolumab | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Name | Type | Description |
|---|---|---|
| Pegilodecakin | BIOLOGICAL | Pegilodecakin plus FOLFOX |
| FOLFOX | DRUG | FOLFOX Alone |
| Paclitaxel or Docetaxel and Carboplatin or Cisplatin | DRUG | Platinum/ Taxane administered IV on Day 1 of every 21 day cycle |
| FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) | DRUG | FOLFOX administered IV on Day 1 and 2 of every 14 day cycle |
| gemcitabine/nab-paclitaxel | DRUG | Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle. |
| Capecitabine | DRUG | Capecitabine administered orally twice daily for 14 days out of every 21 days. |
| Pazopanib | DRUG | Pazopanib administered orally daily continuously |
| Pembrolizumab | DRUG | Pembrolizumab administered IV on Day 1 of every 21 day cycle. |
| Paclitaxel | DRUG | Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle) |
| nivolumab | DRUG | Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle) |
| Gemcitabine/carboplatin | DRUG | Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle) |
Inclusion Criteria: 1. The presence of metastatic pancreatic adenocarcinoma 2. Measurable disease per RECIST v.1.1 3. Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan 4. Eastern Coope...
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Pegilodecakin is an investigational oncology drug developed by Eli Lilly and Company for the treatment of melanoma and pancreatic cancer. It is a small molecule that acts as an agonist at the IL10RA and IL10RB receptors. It has been studied in clinical trials but is not described as approved.
Pegilodecakin targets IL10RA and IL10RB, the alpha and beta subunits of the interleukin-10 receptor. It acts as an agonist at these receptors, meaning it activates IL10 receptor signaling. This receptor agonist activity is the basis for its investigation as an oncology therapy in melanoma and pancreatic cancer.
Pegilodecakin is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trials evaluating the drug in pancreatic cancer and advanced solid tumors, including melanoma.
Pegilodecakin is in Phase 1 development. A Phase 1 study in advanced solid tumors has been completed, and a Phase 3 study in metastatic pancreatic cancer has also been completed. The drug is investigational and is not described as FDA approved.
Pegilodecakin has been studied in two completed trials. NCT02923921 was a Phase 3 study of Pegilodecakin plus FOLFOX versus FOLFOX alone as second-line treatment in metastatic pancreatic cancer, enrolling 567 participants. NCT02009449 was a Phase 1 study in advanced solid tumors, including melanoma, enrolling 353 participants.
Pegilodecakin has been evaluated in metastatic pancreatic cancer as a second-line treatment combined with FOLFOX chemotherapy. The Phase 3 trial NCT02923921 compared Pegilodecakin plus FOLFOX against FOLFOX alone in 567 participants across the United States, Europe, Asia, and Australia. The study is completed.