Prevascar (ilodecakin) / Eli Lilly - LARVOL DELTA

Responses and durability in NSCLC treated with pegilodecakin and anti-PD-1. (ASCO 2018) - P1; "... Pretreated NSCLC subjects (n = 34), received pegilodecakin (10-20g/kg QD, SC) with pembrolizumab (2mg/kg, q3wk IV; n = 5) or nivolumab (3mg/kg, q2wk IV; n = 29)... Pegilodecakin when added to anti-PD-1 therapy in advanced NSCLC patients was associated with response rates and durability of benefit greater than has been seen with anti-PD-1 alone. Responses were seen in settings in which anti-PD-1 therapy has demonstrated limited benefit, such as absent PD-L1 expression, low TMB and/or the presence of liver metastasis. These preliminary findings support further studies of pegilodecakin with anti-PD-1 therapies."

IO biomarker • PD(L)-1 Biomarker • Tumor mutational burden • Hepatocellular Cancer • Non Small Cell Lung Cancer

Pegilodecakin with nivolumab (nivo) or pembrolizumab (pembro) in patients (pts) with metastatic renal cell carcinoma (RCC). (ASCO 2018) - P1; "Pegilodecakin with nivo or pembro is well-tolerated in mRCC pts; the recommended phase 2 dose is 10ug/kg. The efficacy and the observed CD8+ T cell activation are very encouraging."

Clinical • IO biomarker • PD(L)-1 Biomarker • Renal Cell Carcinoma

Pegilodecakin with nivolumab (nivo) or pembrolizumab (pembro) in patients (pts) with metastatic renal cell carcinoma (RCC). (ASCO 2018) - P1; "Pegilodecakin with nivo or pembro is well-tolerated in mRCC pts; the recommended phase 2 dose is 10ug/kg. The efficacy and the observed CD8+ T cell activation are very encouraging."

Clinical • IO biomarker • PD(L)-1 Biomarker • Renal Cell Carcinoma

Responses and durability in NSCLC treated with pegilodecakin and anti-PD-1. (ASCO 2018) - P1; "... Pretreated NSCLC subjects (n = 34), received pegilodecakin (10-20g/kg QD, SC) with pembrolizumab (2mg/kg, q3wk IV; n = 5) or nivolumab (3mg/kg, q2wk IV; n = 29)... Pegilodecakin when added to anti-PD-1 therapy in advanced NSCLC patients was associated with response rates and durability of benefit greater than has been seen with anti-PD-1 alone. Responses were seen in settings in which anti-PD-1 therapy has demonstrated limited benefit, such as absent PD-L1 expression, low TMB and/or the presence of liver metastasis. These preliminary findings support further studies of pegilodecakin with anti-PD-1 therapies."

IO biomarker • PD(L)-1 Biomarker • Tumor Mutational Burden • Hepatocellular Cancer • Non Small Cell Lung Cancer

Overall survival of PEGylated pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC). (ASCO 2018) - P1; "NCT02009449 Background: The therapeutic options for 2nd line therapy PDAC remain unsatisfying with 5-FU/LV plus oxaliplatin or nal-irinotecan resulting in a mOS of 5-6 mo... AM0010 in combination with FOLFOX is well tolerated in patients with metastatic PDAC, and has a reduced incidence of FOLFOX related neuropathy. Immune activation and overall survival are encouraging in this advanced PDAC population. This regimen is currently being studied in a phase 3 trial."

Clinical • Pancreatic Cancer

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=350; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Nov 2020 ➔ May 2021

Clinical • Trial completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • MRI

Sequoia: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3; N=567; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

"Guess we can expect $lly to pair pegilodecakin with their upcoming wave of PD1/-L1 (I assume) & TIM3 bispecifics" (@NotthatkindofDr)

Bispecific • Biosimilar

Renovo: Unaudited interim results for the six months ended 31 March 2012 (Renovo) - The Prevascar trial reported on 16 April 2012 & Renovo decided not to incur any further costs on this programme

Product update • Fibrosis

Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=52; Terminated; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Terminated; The CYPRESS-2 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.

Clinical • Combination therapy • IO Biomarker • Trial termination

Cypress 1: Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=99; Terminated; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Terminated; The CYPRESS-1 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.

Clinical • Combination therapy • IO Biomarker • Trial termination

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=350; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Feb 2020 ➔ Nov 2020

Clinical • Trial completion date • MRI

Cypress 1: Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Nov 2022 ➔ Mar 2020

Clinical • Combination therapy • IO Biomarker • Trial completion date • PD-L1

Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Aug 2022 ➔ Feb 2020

Clinical • Combination therapy • IO Biomarker • Trial completion date

Cypress 1: Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: ARMO BioSciences

Clinical • Combination therapy • IO Biomarker • New P2 trial

Cypress 1: Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: May 2022 ➔ Nov 2022

Clinical • Combination therapy • IO Biomarker • Trial completion date

Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • IO Biomarker

Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Feb 2022 ➔ Aug 2022

Clinical • Combination therapy • IO Biomarker • Trial completion date

Willow 3: A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Eli Lilly and Company

Clinical • New P1 trial

Cypress 1: Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Enrollment closed

Sequoia: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3; N=566; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Enrollment closed

Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • IO Biomarker • PD(L)-1 Biomarker

Sequoia: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3; N=566; Recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Mar 2020 ➔ Sep 2019

Clinical • Combination therapy • Trial primary completion date

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=350; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Feb 2020 ➔ Feb 2019

Clinical • Trial primary completion date

Cypress 2: Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting; N=100 ➔ 50

Clinical • Combination therapy • Enrollment change • Enrollment closed • IO Biomarker • PD(L)-1 Biomarker