Avastin’s FDA Approval in First-line Ovarian Cancer

Contributor : Carolina Do Pazo; Business Insights Analyst

Publish date: 15 Jun, 2018

How Will this Development Impact the Treatment Landscape?

Finally, Avastin’s label in the United States mirrors the European approval. Avastin received FDA approval in combination with chemotherapy followed by Avastin maintenance therapy for advanced stage ovarian cancer following initial surgery on the 13th of June 2018.1 Avastin has long been approved for the first-line treatment of advanced ovarian cancer in Europe (December 2011) and Japan (November 2013). Approval was based on the results of the randomized Phase III GOG-0218 trial (clinicaltrials.gov; NCT00262847), and in Europe data from Phase III ICON7 trial (clinicaltrials.gov; NCT00483782) also supported approval.

Data supporting Avastin’s approval in first-line

Back in 2010, Roche announced at ASCO that the first-line Phase III GOG-0218 trial met its primary endpoint, demonstrating an improvement in progression-free survival (PFS) in patients receiving Avastin with and following chemotherapy compared to chemotherapy alone.2

At this year’s ASCO however, GOG-0218 failed to impress on its key secondary endpoint of final overall survival (OS).3 Overall, in the intention-to-treat population, there were no OS differences between patients receiving Avastin compared to chemotherapy alone. In a subset analysis, a trend towards an OS benefit for patients with FIGO stage IV disease was observed in the Avastin plus chemotherapy followed by Avastin maintenance arm. Even though these results are disappointing, the FDA has concluded that an improvement in PFS is sufficient for granting Avastin’s approval for first-line advanced ovarian cancer.

Table 1. Efficacy results of GOG-0218 trial1



 

How the FDA decision will impact the ovarian cancer market?

Despite not having an official approval in the first-line setting DRGs primary market research indicates that Avastin has held significant off-label patient share in this setting since the 2011 EMA approval. In 2016 Avastin garnered $130 million in sales for this setting alone. Even with official FDA approval US physicians will still face the difficult challenge of weighing up the potential benefits, the toxicities related to this therapy and the high costs of associated with Avastin maintenance in the first-line setting.

Indeed, experts interviewed by DRG believe that the FDA’s decision is unlikely to push the needle significantly on first-line Avastin prescribing and that the real future for the agent rests on its combination use with other agents. The Phase III PAOLA-1 trial is evaluating the combination of Avastin and AstraZeneca’s Lynparza as a maintenance treatment in patients with advanced ovarian cancer following first-line platinum-based chemotherapy and Avastin induction therapy.

Interviewed experts are excited by the scientific rationale of combining an angiogenesis inhibitor and a PARP inhibitor, and are encouraged by data from other combination trial, e.g. cediranib and Lynparza4. A synergistic effect from this combination could result in a real “win” for Avastin in the first-line. At DRG, we continue to keep a finger on the pulse of the ovarian cancer market—stay tuned for more insights and analysis! See our content on the Ovarian Cancer Disease Landscape & Forecast - we’ll update the market forecast with a 2017 base-year in Q3 2018.

References:

  1. Roche press release “FDA approves Roche’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery”, 13 June 2018. Available at: https://www.roche.com/media/releases/med-cor-2018-06-13.htm
  2. Perren TJ, et al. A Phase 3 Trial of Bevacizumab in Ovarian Cancer. The New England Journal of Medicine. 2011; 365:2484-2496.
  3. Burger RA, et al. Final overall survival (OS) analysis of an international randomized trial evaluating bevacizumab (BEV) in the primary treatment of advanced ovarian cancer: A NRG oncology/Gynecologic Oncology Group (GOG) study. Journal of Clinical Oncology. 2018; 36 (suppl; abstract 5517).
  4. Liu JF, et al. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer : a randomized Phase 2 study. The Lancet Oncology. October 2014;15(11):1207-1214.

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