The tyrosine kinase inhibitor regorafenib is approved for the management of mCRC patients who have failed standard therapy. It has been shown to reduce immunosuppressive tumour-associated macrophages (TAMs) and to synergize with anti-PD1 inhibition in a preclinical model of microsatellite-stable CRC [1,2].
REGOMUNE is a phase 1/2 study evaluating the efficacy and safety of the combination regorafenib and avelumab, an anti-PDL1 antibody, in solid tumours [3]. In Cohort A, 48 patients with non-MSI-high mCRC were enrolled. Patients were treated with regorafenib (160 mg once daily, 3 weeks on/1 week off) plus avelumab (10 mg/kg every 2 weeks) until progression of disease. Median follow-up was 7.2 months. Primary endpoint was the confirmed objective response rate, based on central review according to RECIST 1.1. Secondary endpoints included 1-year PFS, 1-year OS, and safety.
A total of 12 patients (30%) had a reduction in tumour burden. Best response was stable disease for 23 patients (57.5%) and progressive disease for 17 patients (42.5%). Median PFS was 3.6 months, median OS was 10.8 months. Increased tumour infiltration by CD8-positive T cells at day 1 of the second treatment cycle was significantly associated with better PFS and OS (P=0.011). Combining low TAM infiltration and low distance between tumour cells and CD8-positive T cells enabled the identification of a subgroup of patients (25%) who are more likely to benefit from the regorafenib plus avelumab combination: median PFS 5.3 months versus 1.9 months (P=0.037); median OS not reached versus 5.3 months (P=0.02).
Almost all patients (87%) experienced grade ≥3 adverse events. The most common grade ≥3 adverse events were palmar-plantar erythro-dysesthesia syndrome (29.8%), hypertension (23.4%), and diarrhoea (12.8%). No death was related to the treatment.
- Abou-Elkacem L, et al. Mol Cancer Ther. 2013; 12: 1322-1331.
- Hoff S, et al. Ann Oncol 2017; 25 (suppl), abstract 11989P.
- Cousin S, et al. ASCO Virtual Meeting, 29-31 May 2020, Abstract 4019
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Table of Contents: ASCO 2020
Featured articles
COVID-19 & Telemedicine
COVID-19 and Cancer Consortium Registry: initial results
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Nurse-led telephone triage system reduces hospitalizations, helps patients manage symptoms at home
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Adjuvant pembrolizumab: durable RFS for stage III melanoma
Adjuvant pembrolizumab: durable RFS for stage III melanoma
Pembrolizumab plus low-dose ipilimumab well tolerated after progression on PD1 antibody therapy
Toripalimab plus axitinib effective in metastatic mucosal melanoma
Breast & Ovarian Cancer
Advanced breast cancer: locoregional therapy does not improve OS
T-DM1 does not improve safety or efficacy in HER-2 positive early breast cancer; favorable iDFS reported
Maintenance olaparib improves OS in relapsed ovarian cancer with BRCA1/2 mutation
Combination pembrolizumab/chemo improves PFS in metastatic TNBC
Effect of veliparib with or without cisplatin in breast cancer: results of SWOG S1416
PHOEBE, a phase 3 trial comparing pyrotinib and lapatinib in HER2-positive metastatic breast cancer
BYLieve demonstrates efficacy of PIK3CA-directed treatment post CDK4/6-ihibition
Strategies emerge for chemotherapy de-escalation in HER2-positive breast cancer
Multiple Myeloma
Carfilzomib: no PFS benefit for multiple myeloma
Lung Cancer
ES-SCLC: tremelimumab + durvalumab + chemotherapy misses endpoint
Adjuvant osimertinib in NSCLC: practice changing ADAURA trial
ES-SCLC: pembrolizumab KEYNOTE-604 data
Second-line gemcitabine plus ramucirumab significantly improves overall survival
Tiragolumab and atezolizumab: ORR in NSCLC
MET-amplified advanced NSCLC responds well to MET inhibitor capmatinib
Genitourinary Cancer
Urothelial cancer: avelumab works as maintenance therapy
ARAMIS final OS and nmCRPC safety outcomes
Final survival results from phase 3 SPARTAN trial
Novel drug for kidney cancers/VHL patients
Primary analysis from IMvigor010, adjuvant atezolizumab in high risk muscle-invasive urothelial carcinoma
First randomised trial of Lu-PSMA in mCRPC progressing after docetaxel
Gastrointestinal Cancer
HER2-expressing metastatic colorectal cancer: trastuzumab deruxtecan
REGOMUNE: a phase 2 study combining regorafenib and avelumab
Cardiotoxicity: consider switching to S-1
Perioperative chemotherapy for resectable pancreatic ductal adenocarcinoma
Real-world data of sequential sorafenib followed by regorafenib in unresectable HCC
Paediatric Cancer
Sustained improvements in quality of life with larotrectinib
Promising first immunotherapy trial in placental trophoblastic tumours
Precision medicine for poor-prognosis paediatric patients
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