NCCN Guidelines for Ovarian Cancer V Meeting on 11/15/17

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1 OV-1 External request: Submission from Vermillion/ASPiRA Laboratories to consider: Inclusion of the following recommendation in the workup for suspected ovarian cancer: OVA1 and/or Multivariate Index Assay (MIA) or other tumor markers as clinically indicated. Inclusion of the following recommendation with the primary treatment options: Establish baseline CA125 as clinically indicated either from OVA1 and/or MIA results or separately. OV-4 Institutional Review comment to reassess the inclusion of paclitaxel as a maintenance therapy option following primary therapy for stage II-IV disease. OV-4 Institutional Review comment to reassess the inclusion of pazopanib as a maintenance therapy option following primary therapy for stage II-IV disease. Based on the data in the references noted in the submission, the panel consensus did not support the addition of these specific recommendations into the Guidelines. Based on the discussion and noted reference, the panel consensus was to remove paclitaxel as a maintenance therapy option following primary therapy for stage II-IV ovarian/fallopian tube/primary peritoneal cancer, due to limited available data. Copeland LJ, Brady MF, Burger RA, et al. A phase III trial of maintenance therapy in women with advanced ovarian/fallopian tube/peritoneal cancer after a complete clinical response to first-line therapy: An NRG oncology study [abstract]. Gyn Oncol 2017;145: abstract 219. Based on the discussion and noted reference, the panel consensus supported the continued listing of pazopanib as a maintenance therapy option for patients with complete clinical remission following primary therapy without bevacizumab, for stage II-IV ovarian/fallopian tube/primary peritoneal cancer. This recommendation changed from a category 2B to a category 3 due to limited available data. Copeland LJ, Brady MF, Burger RA, et al. A phase III trial of maintenance therapy in women with advanced ovarian/fallopian tube/peritoneal cancer after a complete clinical response to first-line therapy: An NRG oncology study [abstract]. Gyn Oncol 2017;145: abstract

2 OV-4 Institutional review comment to consider the inclusion of bevacizumab as a maintenance therapy option following primary therapy for stage II-IV disease, for patients that received bevacizumab as part of primary therapy. OV-6 Internal and external requests: Institutional review comment and submission from Clovis Oncology, Inc., to consider the inclusion of rucaparib as a maintenance therapy option for patient with platinum-sensitive relapsed ovarian cancer. OV-6 Panel comment to consider the inclusion of bevacizumab as a maintenance therapy option following platinum-based recurrence therapy including bevacizumab for platinum-sensitive relapsed/recurrent disease. panel consensus was to include bevacizumab as a maintenance therapy option for stage II-IV ovarian/fallopian tube/primary peritoneal cancer, if partial or complete remission following primary therapy including bevacizumab. This is a category 2A recommendation. Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011;365: panel consensus was to include rucaparib as a maintenance therapy option for consideration for patients with platinumsensitive relapsed or recurrent ovarian cancer (including LCOH), Fallopian tube cancer, and primary peritoneal cancer, if partial or complete response following platinumbased therapy. This is a category 2A recommendation. Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017; 390(10106): panel consensus was to include the continuation of bevacizumab as a maintenance therapy option for those with recurrent platinum-sensitive disease, if there is a partial or complete response following a platinum-based recurrence therapy including bevacizumab. This is a category 2A recommendation. Aghajanian C, Blank SV, Goff BA, et al. OCEANS: A randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012;30:

3 LCOH-4 Institutional review comment to consider the option of including bevacizumab with the following adjuvant therapies for stage II-IV mucinous carcinoma of the ovary: 5-FU + leucovorin Capecitabine + oxaliplatin Based on the discussion, the panel consensus was to include the following adjuvant therapy options for stage II-IV mucinous carcinoma of the ovary. These are category 2B recommendations. 5-FU + leucovorin + bevacizumab (category 2B) Capecitabine + oxaliplatin + bevacizumab (category 2B) LCOH-5/OV-B (4 of 10) Institutional review comment to consider adding exemestane to the hormone therapy options for stage IC-IV, low-grade serous/grade 1 endometrioid epithelial carcinoma. Based on the discussion, the panel consensus was to include exemestane as one of the aromatase inhibitor, hormone therapy options for stage IC-IV, low-grade serous/grade 1 endometrioid epithelial carcinoma. This is a category 2B recommendation. LCOH-5 Institutional review comment to consider adding the option of maintenance hormonal therapy after adjuvant chemotherapy. panel consensus was to add the option of maintenance hormonal therapy (ie. aromatase inhibitors [anastrozole, letrozole, exemestane], leuprolide acetate, tamoxifen) after adjuvant chemotherapy for patients with stage II-IV low-grade serous/grade 1 endometrioid epithelial carcinoma. This is a category 2B recommendation. Gershenson DM, Bodurka DC, Coleman RL, et al. Hormonal maintenance therapy for women with low-grade serous cancer of the ovary or peritoneum. J Clin Oncol 2017; 35(10):

4 OV-B (2 of 10) Institutional review comment to consider adding the following intravenous (IV) primary therapy options for patients >age 70 with stage I-IV ovarian cancer (including LCOH), Fallopian tube cancer, and primary peritoneal cancer: Carboplatin (every 3 weeks) Paclitaxel/carboplatin (every 3 weeks) Paclitaxel/carboplatin (weekly) OV-B (3 of 10) Institutional Review comment to consider specifying the primary systemic therapy options for stage I ovarian epithelial cancer (including less common ovarian histopathologies [LCOH])/Fallopian tube cancer/primary peritoneal cancer. panel consensus was to include the following IV primary therapy options for stage I-IV ovarian cancer (including LCOH), Fallopian tube cancer, and primary peritoneal cancer. They are category 2A recommendations. Carboplatin AUC 5 given every 3 weeks Paclitaxel 135 mg/m2 + carboplatin AUC 5 given every 3 weeks Paclitaxel 60 mg/m2 IV over 1 hour followed by carboplatin AUC 2 IV over 30 minutes. Weekly for 18 weeks. von Gruenigen VE, Huang HQ, Beumer JH, et al. Chemotherapy completion in elderly women with ovarian, primary peritoneal or fallopian tube cancer - An NRG oncology/gynecologic Oncology Group study. Gynecol Oncol 2017; 144(3): Based on the data in the noted references and discussion, the panel consensus was to include the following primary systemic therapy options for stage I ovarian epithelial cancer (including LCOH)/Fallopian tube cancer/primary peritoneal cancer. The regimens are category 2A recommendations. Paclitaxel/carboplatin (preferred) Liposomal doxorubicin/carboplatin (PLD) References: Ozols RF, Bundy BN, Greer BE, et al. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol 2003; 21(17): Pignata S, Scambia G, Ferrandina G, et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: The MITO-2 Randomized Phase III Trial. J Clin Oncol 2011; 29(27):

5 OV-B (3 of 10) Panel discussion to consider reassessing the categories of evidence for the primary systemic therapy options for stage II-IV ovarian epithelial cancer (including LCOH)/Fallopian tube cancer/primary peritoneal cancer. Based on the discussion, the panel consensus supported the continued listing of the following primary systemic therapy options for stage II-IV ovarian epithelial cancer (including LCOH)/Fallopian tube cancer/primary peritoneal cancer. The following regimens changed from category 1 to category 2A recommendations due to limited comparison data: IP/IV paclitaxel/cisplatin (for optimally debulked stage II-III disease) Paclitaxel/carboplatin (weekly) Dose-dense paclitaxel/carboplatin Paclitaxel/carboplatin (every 3 weeks) Docetaxel/carboplatin The following regimens changed from category 2B to category 2A recommendations: Paclitaxel/carboplatin/bevacizumab (per ICON-7) Paclitaxel/carboplatin/bevacizumab (per GOG-218) OV-B (5 of 10) External request: Submission from EMD Serono, Inc. and Pfizer Inc., to consider addition of avelumab as a treatment option for recurrent/refractory ovarian cancer. OV-B (5 of 10) External request: Submission from Genentech, Inc., to consider the data for the use of carboplatin/paclitaxel/bevacizumab in recurrent, platinum-sensitive ovarian cancer. OV-B (5 of 10) Panel discussion to review the data for the use of the following recurrence therapy options for platinum-sensitive ovarian cancer: Carboplatin/paclitaxel Carboplatin/liposomal doxorubicin Based on the data in the references noted in the submission, the panel consensus did not support the addition of avelumab as a treatment option for recurrent/refractory ovarian cancer. See Submission for references. Based on the data in the reference noted in the submission, the panel consensus supported the continued inclusion of carboplatin/paclitaxel/bevacizumab as a recurrence therapy option for platinum-sensitive ovarian cancer. This regimen has been moved to the list of preferred options. Based on the discussion, the panel consensus supported the continued listing of the following recurrence therapy options for platinum-sensitive ovarian cancer. These changed from category 1 to category 2A recommendations due to limited comparison data. Carboplatin/paclitaxel Carboplatin/liposomal doxorubicin

6 OV-B (6 of 10) Institutional review comment to consider specifying the aromatase inhibitors that can be used as acceptable recurrence therapy options. OV-B (8 of 10) Panel discussion to consider adding exemestane to the hormone therapy options for recurrent malignant sex cord-stromal tumors. Based on the discussion, the panel consensus supported the inclusion of the following aromatase inhibitors as acceptable recurrence therapy options for ovarian cancer: Anastrozole Exemestane Letrozole Based on the discussion, the panel consensus was to include exemestane as one of the aromatase inhibitors, hormonal therapy options for recurrent, malignant sex cord-stromal tumors. This is a category 2A recommendation.