Featured video: Phase III interim analysis examining maintenance treatment with the immunotherapy avelumab after platinum-based first-line chemotherapy in advanced bladder cancer
First-line, platinum-based chemotherapy for advanced bladder cancer is characterised by frequent resistance, and PD-L1/PD-1 inhibitors, such as avelumab, are standard second-line treatment for patients with disease progression; however, only a minority of patients obtains a durable clinical benefit [2]. The JAVELIN Bladder 100 trial investigated avelumab as first-line maintenance therapy in patients whose disease had not progressed with first-line platinum-based induction chemotherapy.
Participants (n=700) underwent 4-6 cycles of standard platinum-based chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine), followed by a treatment-free interval between 4-10 weeks. Then, 350 patients were randomised to receive avelumab (10 mg/kg IV every 2 weeks) and best supportive care (BSC; e.g. antibiotics, nutrition, hydration, pain management), while the other 350 patients received BSC alone. Co-primary endpoints were overall survival in (1) all randomised patients, and (2) the PD-L1-positive population. Secondary endpoints were progression-free survival, objective response per RECIST 1.1, safety and tolerability, and patient-reported outcomes.
The primary endpoints were both met; the median overall survival for the avelumab + BSC arm was 21.4 months versus 14.3 months for BSC alone in the overall population (HR 0.69; 95% CI 0.56-0.86; P<0.001), and was better in the PD-L1-positive patients as well (n=61/189 in the avelumab + BSC arm; n=82/169 in the BSC alone arm; HR 0.56; 95% CI 0.40-0.78, see Figure). However, Prof. Powles pointed out that the patients that had PD-L1-negative or unknown status also showed benefit, and that all prespecified subgroup analyses broadly favoured the avelumab group. The secondary progression-free survival endpoint was also significant; in the avelumab + BSC arm, progression-free survival was 3.7 months as compared with 2.0 months for BSC alone (HR 0.62; 95% CI 0.52-0.75; P<0.001). The safety profile of avelumab as first-line maintenance was manageable and consistent with previous studies of avelumab monotherapy.
In conclusion, this late-breaker abstract highlighted the statistically significant improvement in overall survival observed with the combination of the PD-L1 inhibitor avelumab plus BSC versus BSC alone in patients with advanced urothelial carcinoma followed platinum-based chemotherapy in the frontline setting. Based on the JAVELIN Bladder 100 findings, the FDA has granted a breakthrough therapy designation to avelumab in this setting. Prof. Powles closed his presentation by stating that “overall, avelumab first-line maintenance in patients whose disease has not progressed with platinum-based induction therapy is a new first-line standard of care of advanced urothelial cancer.”
Figure. Avelumab combined with best supportive care (BSC) significantly prolonged overall survival (OS) compared with BSC alone [1]
- Powles T. ASCO Virtual Meeting, 29-31 May 2020, Abstract
- Simeone JC, et al. Cancer Epidemiol. 2019;60:121‐127.
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Table of Contents: ASCO 2020
Featured articles
COVID-19 & Telemedicine
COVID-19 and Cancer Consortium Registry: initial results
Oncology hospital-at-home model reduces hospitalizations, emergency department visits, and costs
Nurse-led telephone triage system reduces hospitalizations, helps patients manage symptoms at home
Melanoma
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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