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Proffered Paper 1 – Gastrointestinal tumours, non-colorectal

3502 - Randomised Efficacy and Safety Results For Atezolizumab (Atezo) + Bevacizumab (Bev) in Patients (pts) With Previously Untreated, Unresectable Hepatocellular Carcinoma (HCC)

Date

27 Sep 2019

Session

Proffered Paper 1 – Gastrointestinal tumours, non-colorectal

Topics

Tumour Site

Hepatobiliary Cancers

Presenters

Michael Lee

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

M. Lee1, B. Ryoo2, C. Hsu3, K. Numata4, S. Stein5, W. Verret6, S. Hack6, J. Spahn6, B. Liu7, H. Abdullah8, R. He9, K. Lee10

Author affiliations

  • 1 Unc Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27514 - Chapel Hill/US
  • 2 Dept. Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 3 Department Of Oncology, National Taiwan University Hospital, 10002 - Taipei City/TW
  • 4 Department Of Gastroenterology, Yokohama City University Medical Center, Yokohama/JP
  • 5 Medical Oncology, Yale School of Medicine, New Haven/US
  • 6 Product Development - Oncology, Genentech, Inc., South San Francisco/US
  • 7 Biostatistics. Pdbb, Genentech, Inc., South San Francisco/US
  • 8 Safety Science Oncology, Genentech, Inc., South San Francisco/US
  • 9 Department Of Medicine, Georgetown University Medical Center, Washington/US
  • 10 Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR

Resources

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Abstract 3502

Background

Pts with unresectable HCC have few treatment (tx) options. Checkpoint inhibitors and combination approaches with anti-VEGFs are emerging as potential new tx options. Here we report the first randomised dataset evaluating atezo (anti-PD-L1) as monotherapy vs the combination of atezo + bev (anti-VEGF; Arm F) as well as updated single-arm atezo + bev data (Arm A) from a Ph 1b study.

Methods

Arms F and A of the Ph 1b study GO30140 enrolled systemic tx-naïve pts with unresectable HCC. Arm F pts were randomised 1:1 to atezo + bev or atezo monotherapy and received atezo 1200 mg IV q3w, bev 15 mg/kg IV q3w until unacceptable toxicity or loss of clinical benefit. Arm A pts received atezo + bev. Primary endpoints were progression free survival (PFS; Arm F) and objective response rate (ORR, Arm A) by independent review facility (IRF)-assessed RECIST 1.1, and safety (Arms F and A).

Results

In Arm F, 60 pts were randomised to atezo + bev (Group F1) and 59 pts to atezo (Group F2). Arm F showed a statistically significant improvement in the primary endpoint median PFS for atezo + bev vs atezo (5.6 vs 3.4 mo, HR 0.55, 80% CI, 0.40 – 0.74, P = 0.0108). Any-Gr TRAEs occurred in 41 (68%) F1 pts and 24 (41%) F2 pts; Gr 3-4 TRAEs occurred in 12 (20%) F1 pts and 3 (5%) F2 pts. There were no Gr 5 TRAEs in Arm F. For the 104 pts in Arm A, primary endpoint ORR was 36% (37 pts) with 76% ongoing. Any-Grade (Gr) tx-related adverse events (TRAEs) occurred in 91 (88%) pts; Gr 3-4 TRAEs occurred in 41 (39%) pts. Gr 5 TRAEs were seen in 3 (3%) pts.

Conclusions

By meeting its primary endpoint of improved PFS for atezo + bev vs atezo alone, Arm F showed the single-agent contribution of atezo and bev to the overall tx effect. With longer follow up, Arm A highlights the clinically meaningful and durable responses of atezo + bev. Coupled with a tolerable safety profile, these data suggest that atezo + bev is a promising first-line tx option for unresectable HCC.

Clinical trial identification

NCT02715531.

Editorial acknowledgement

Medical writing assistance was provided by Steffen Biechele, PhD, of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffmann-La Roche, Ltd.

Disclosure

M. Lee: Research grant / Funding (self): Amgen; Research grant / Funding (self): Bristol-Myers Squibb ; Research grant / Funding (self): Pfizer; Research grant / Funding (self): EMD Serono; Research grant / Funding (self): Genentech/Roche. C. Hsu: Honoraria (institution), Advisory / Consultancy: BMS; Honoraria (institution), Advisory / Consultancy: Ono Pharmaceutical; Honoraria (institution), Research grant / Funding (self): MSD; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: AZ; Advisory / Consultancy: Roche. S. Stein: Advisory / Consultancy: Genentech; Advisory / Consultancy: BMS; Advisory / Consultancy: Eisai; Advisory / Consultancy: Bayer; Advisory / Consultancy: Exelixis. W. Verret: Full / Part-time employment: Genentech/Roche. S. Hack: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech/Roche. J. Spahn: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech/Roche. B. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech/Roche. H. Abdullah: Full / Part-time employment: Genentech/Roche. R. He: Speaker Bureau / Expert testimony: Bayer; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Eisai Inc.; Speaker Bureau / Expert testimony: Exelixis Inc; Advisory / Consultancy, Research grant / Funding (institution): Merck & Co; Advisory / Consultancy: AZ. K. Lee: Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Eisai; Honoraria (self): Ono Pharmaceuticals; Honoraria (self), Speaker Bureau / Expert testimony: Roche; Honoraria (self): Samsung Bioepis; Speaker Bureau / Expert testimony: Eli Lilly. All other authors have declared no conflicts of interest.Table:

LBA39

Arm F
IRF RECIST 1.1IRF HCC mRECIST
F1 Atezo + Bev (n = 60)F2 Atezo (n = 59)aF1 Atezo + Bev (n = 60)F2 Atezo (n = 59)a
Median follow-up, mo6.66.76.66.7
Median PFS, mo 95% CI5.6b 3.6 – 7.43.4b 1.9 – 5.25.6 3.6 – 7.43.4 1.9 – 5.2
HR0.55b0.54
80% CI0.40 – 0.74 P = 0.01080.40 – 0.74
Arm A: Atezo + Bev
n = 104
IRF RECIST 1.1IRF HCC mRECIST
Median follow-up, mo12.4
Confirmed ORR, n (%)37 (36)b41 (39)
95% CI (%)26 – 4630 – 50
Complete Response (CR), n (%)12 (12)16 (15)
Partial Response (PR), n (%)25 (24)25 (24)
On-going response, n (%)28 (76)28 (68)
DCR (CR + PR + SD), n (%)74 (71)74 (71)
Median DOR, moNENE
95% CI11.8 – NE11.8 – NE
Median PFS, mo7.37.3
95% CI5.4 – 9.95.4 – 9.9

DCR, disease control rate; DOR, duration of response; NE, not estimable; SD, stable disease. Data cut off: 14 June 2019.

a

1 randomised pt did not receive atezo.

b

Primary endpoint.

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