Abstract 3887
Background
Among pts with St III unresectable NSCLC, only 15% are alive at 5 years with the historical Standard of Care (SoC) of definitive cCRT. Durvalumab, a human monoclonal anti-PD-L1 antibody, demonstrated efficacy in PFS and OS and was approved in Europe on September 2018 for the treatment of St III unresectable NSCLC expressing PD-L1 ≥ 1% and without progression after CRT. ATU permits the access to innovative medicines for pts without alternatives before a market authorization is granted.
Methods
Durvalumab was administrated to pts as a 60 min intravenous infusion at 10 mg/kg every 2 weeks for a maximum of 12 months, or discontinuation due to progressive disease, Adverse Events (AE) or switch to commercial drug. Pts characteristics and safety data were prospectively collected during cATU.
Results
From March 26th to October 28th 2018, 188 sites requested a cATU for 591 pts with St III unresectable NSCLC who did not progress after cCRT, independently of their PD-L1 status. 561 pts were treated by Durvalumab (27 pts were treated with the commercial drug & 3 pts were lost to follow-up). 71.6% of pts were men, median age was 62.4±8.9 years. 51.7% of tumours were adenocarcinoma. 40.5% of pts were in St IIIA, 51.8% in St IIIB and 6.2% in St IIIC. All pts were treated with platinum-based cCRT, with a median dose of 66 Gy [45.0-74.0] and 54% with cisplatin-based chemotherapy. Best response to cCRT was partial response for 78.5% of pts, complete response for 6.3% and stable disease for 15.2%. By January 2019, 82.1 % of pts were still under Durvalumab and 46.3% pts treated more than 6 months. Overall, drug related AEs occurred in 17.3% of pts including 8.2% serious AEs. Most common Durvalumab related AEs (all grades) were hyperthyroidism (1.2%) and pneumonitis (1.1% or n = 6, including one death). Discontinuation occurred in 17.8% of pts, of which 5.2% were Durvalumab related.
Conclusions
These data confirm that Durvalumab has a manageable safety profile in real-life practice. Enrollment of 591 pts in 7 months highlights the high unmet need for stage III unresectable NSCLC pts and supports Durvalumab treatment as the new SoC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
V. Avrillon: Advisory / Consultancy: Bristol-Myers Squibb (BMS); Travel / Accommodation / Expenses, congress invitation: Merck Sharp & Dohme (MSD); Advisory / Consultancy: AbbVie; Advisory / Consultancy: Bristol-Myers Squibb (BMS); Advisory / Consultancy: AbbVie; Travel / Accommodation / Expenses: MSD. E. Pichon: Travel / Accommodation / Expenses: Bristol-Myers Squibb (BMS); Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Merck Sharp & Dohme (MSD). A.T. Stancu: Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Bristol-Myers Squibb (BMS). C. Chouaid: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Clovis; Advisory / Consultancy: Glaxosmithkline; Advisory / Consultancy: Hoffmann-La Roche; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis; Advisory / Consultancy: Amgen. A. Lagrange: Travel / Accommodation / Expenses: Hoffmann-La Roche; Travel / Accommodation / Expenses: Takeda; Travel / Accommodation / Expenses: Bristol-Myers Squibb (BMS). M. Sabatini: Travel / Accommodation / Expenses: Sos Oxygene; Advisory / Consultancy: BMS; Travel / Accommodation / Expenses: Boehringer Ingelheim. G. Eberst: Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: boehringer ingelheim. P. Boisselier: Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: MSD; Honoraria (self): Merck Serono; Honoraria (self): BMS; Honoraria (self): Roche. All other authors have declared no conflicts of interest.
Resources from the same session
4085 - A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-601 in Patients with Advanced Solid Tumors
Presenter: Anthony Tolcher
Session: Poster Display session 1
Resources:
Abstract
1054 - Safety, efficacy, and pharmacokinetic (PK) profile of cosibelimab, an anti‐PD‐L1 antibody, in patients (pts) with advanced cancers
Presenter: Philip Clingan
Session: Poster Display session 1
Resources:
Abstract
4264 - A Phase I study of tinostamustine in patients (pts) with advanced solid tumours
Presenter: Alain Mita
Session: Poster Display session 1
Resources:
Abstract
3811 - Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors
Presenter: Santiago Ponce Aix
Session: Poster Display session 1
Resources:
Abstract
1311 - A phase I study of varlitinib (VAR; ASLAN001) an oral pan-HER tyrosine kinase inhibitor (TKI) combined with mFOLFIRI chemotherapy in advanced solid tumors
Presenter: Aaron Tan
Session: Poster Display session 1
Resources:
Abstract
3482 - Phase I study of lapatinib and trametinib in patients with KRAS mutant colorectal, non-small cell lung and pancreatic cancer
Presenter: Sanne Huijberts
Session: Poster Display session 1
Resources:
Abstract
4749 - Pharmacokinetic (PK) and updated survival data from the Canadian Cancer Trials Group IND.226 study of durvalumab ± tremelimumab in combination with platinum-doublet chemotherapy
Presenter: Desiree Hao
Session: Poster Display session 1
Resources:
Abstract
4530 - A Phase 2a clinical trial combining ALRN-6924 and palbociclib for the treatment of patients with tumors harboring wild-type p53 and MDM2 amplification or MDM2/CDK4 co-amplification
Presenter: Funda Meric-Bernstam
Session: Poster Display session 1
Resources:
Abstract
4280 - Updated Efficacy and Safety of Entrectinib in Patients with NTRK Fusion-Positive Tumors: Integrated Analysis of STARTRK-2, STARTRK-1 and ALKA-372-001
Presenter: Christian Rolfo
Session: Poster Display session 1
Resources:
Abstract
6144 - An international randomized cross-over bio-equivalence study of oral paclitaxel + HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumors
Presenter: Christopher Jackson
Session: Poster Display session 1
Resources:
Abstract