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For Recurrence Breast Cancer TECHBRIEF HORIZON SCANNING REPORT NEUVAX™ (NELIPEPIMUT-S, NP-S) FOR RECURRENCE BREAST CANCER Report No: 006/2019 MaHTAS Medical Development Division Ministry of Health, Malaysia “DOKUMEN TERHAD” TERHAD Prepared by: Dr. Norrina Jamaluddin Principal Assistant Director Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia Reviewed by: Dr. Izzuna Mudla bt Mohamed Ghazali Public Health Physician/Senior Principal Assistant Director Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia Dr. Junainah bt Sabirin Public Health Physician/Deputy Director Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia Disclosure: The author of this report has no competing interest in this subject and the preparation of this report is totally funded by the Ministry of Health, Malaysia. Disclaimer: TechBrief report is prepared based on information available at the time of research and a limited literature. It is not a definitive statement on the safety, effectiveness or cost effectiveness of the health technology covered. Additionally, other relevant scientific findings may have been reported since completion of this report. Horizon Scanning Unit, MaHTAS, Medical Development Division, Ministry of Health, Malaysia, Email: [email protected] Web: http://www.moh.gov.my i | P a g e TERHAD HS08 TechBrief Report No. : 006/2019 NEUVAX™ (NELIPEPIMUT-S, NP -S) FOR RECURRENCE BREAST CANCER SUMMARY it was estimated that 627,000 women died from breast cancer which was NeuVax™ (Nelipepimut-S, NP-S) is an approximately 15% of all cancer deaths investigational immunotherapy being among women.1 developed by SELLAS Life Sciences Group Incorporation to treat human In Malaysia, breast cancer is the most epidermal growth factor 2 (HER2)- common cancer in females. The associated breast cancers. International Agency for Research on Cancer (IARC) reported new cases of The vaccine is given as adjuvant breast cancer comprised of 32.7% of all therapy to prevent breast cancer new cancer cases in female.2 recurrence by binding to the specific HLA molecules on antigen presenting Research on breast cancer vaccine was cells and stimulates specific cytotoxic T intensified following the successful used lymphocyte. These activated CTLs of immunotherapy for melanoma, renal recognized, neutralized and destroyed, cancer, lung cancer, glioblastoma and through cell lysis and HER2 expressing gastric cancer. Since the approval and cancer cells. acceptance of the first peptide vaccine for prostate cancer in 2010, many Limited vaccine efficacy studies showed researches using peptide-based vaccine promising results. The vaccine is easily were carried out.3 The role of the administered, safe and potentially immune system in the emergence of provide significant efficacy for subgroup breast cancer therapy has been firmly triple negative patient. established.4,5,6 Keywords: breast cancer, vaccine, The objective of this early assessment is recurrence, immunotherapy, adjuvant to evaluate effectiveness and safety of therapy, triple negative NeuVax™ in preventing recurrence INTRODUCTION breat cancer. THE TECHNOLOGY Breast cancer is the most frequent cancer among women globally, NeuVax™ (Nelipepimut-S, NP-S) is a impacting 2.1 million women each year. HER2-targeted vaccine being It causes the greatest number of cancer- investigated for breast cancer. related deaths among women. In 2018, 1 | P a g e TERHAD TERHAD NeuVax™ is a combination of E75, a metastatic cancer cells through cell peptide from the extracellular domain of lysis.7,8 HER2 and granulocyte-macrophage colony-stimulating factor (GM-CSF); it Initially, it was developed by Galena stimulates cytotoxic T lymphocytes and BioPharma, Inc. As of December 2017, CD8+ memory cells with high affinity for Galena BioPharma merged with HLA-A2/A3.3 SELLAS Ltd. and formed SELLAS Life Sciences Group Inc. This vaccine NeuVax™ stimulates and activates aimed to prevent or delay the CD8+ CTLs and CD8+ memory cells recurrence of breast cancer in cancer against E75, MHC class I epitope. More survivors who achieve remission after precisely, the activated specific CTLs standard of care treatment (e.g., bind to HLA-A2/A3 molecules on surgery, radiation, chemotherapy). antigen-presenting cells therefore recognizing, neutralizing and destroying HER-2 expressing primary and IMMUNOGENETIC ANTIGEN NeuVax™ Figure 1: Schematic representation of NeuVax™ activity 9 2 | P a g e TERHAD TERHAD Photo by: www.thepharmaletter.com Figure 2: NeuVax™ vaccine PATIENT GROUP AND CURRENT PRACTICE INDICATION According to Clinical Practice NeuVax™ is a breast cancer vaccine Guidelines, Ministry of Health (2010), indicated to prevent or delay the the current management for breast recurrence of breast cancer in cancer cancer will depends on the stage of survivors who achieve remission after diseases. For patient in early stage, standard of care treatment (e.g., surgery is the first line of treatment. Patient may be offered mastectomy; surgery, radiation, chemotherapy). However, the studies only include those with or without axillary clearance or with low expression of HER2 breast conserving surgery (BCS). (Immunohistochemistry [IHC] (1+/2+), and the only significant result was The surgery depends on the risk of improvement in DFS in the subgroup stratification; (1) BCS with axillary analysis of triple negative patients. surgery for low risk patient and (2) Other studies are still ongoing. mastectomy with axillary surgery with or without reconstruction for patients with intermediate or high risk group. 3 | P a g e TERHAD TERHAD For BCS, adjuvant radiotherapy and NeuVax™ is the only breast cancer hormonal therapy may be offered. vaccine that completed Phase 3 clinical Chemotherapy treatment with or trial [PRESENT (Prevention of without Herceptin and adjuvant Recurrence in Early Stage, Node- radiotherapy (with or without hormone Positive Breast Cancer with Low to therapy) may be considered for Intermediate HER2 Expression with intermediate or high risk patients. This NeuVax Treatment)]. The trial treatment is equivalent to patients who compared NeuVax™ plus GM-CSF underwent mastectomy with axillary with placebo plus GM-CSF in surgery (with or without preventing cancer recurrence in reconstruction).10 patients with node positive, HER2 IHC 1+/2+, and HLA-A2+ and/or A3+ For remission breast cancer survivors, patients. (NCT01479244) a psychological support and breast care nursing is provided to gear In addition to PRESENT trial, there are survivor’s needs. Psychological care is three ongoing clinical trials conducted: aim to improve the continuity of care i. Two studies evaluate NeuVax™ in and support them throughout the combination with trastuzumab 10 diagnosis, treatment and follow up. (Herceptin®; Genentech/Roche) for breast cancer. A current practice of combination trastuzumab with chemotherapy leads a) Phase 2b trial in node positive to improved disease-free survival and (or node negative if negative for overall survival compared to no both ER and PR) breast cancer treatment, in people with T1a, T1b and patients with HERS IHC 1+/2+ T1c tumours. Specifically, an additional (NCT01570036) 14% of patient would be free from disease at three years and additional b) Phase 2 trial in high-risk node nine to 15% would be alive at eight positive or negative HER2 IHC years (T1a 14%, T1b 11%, T1c 15%) 3+ patients (NCT02297698) with the combination compared to no ii. A phase 2 clinical trial of NeuVax™ 11 treatment. (Nelipepimut-S) peptide vaccine in women with ductal carcinoma in SAFETY & EFFICACY situ (DCIS). It aims to assess effectiveness of NeuVax™ plus An electronic search of databases such GM-CSF or sargamostim (Leukin®) as PubMed and Embase using in treating patients with DCIS keywords either single or combination; (NCT02636582).12 NeuVax™, peptide-based vaccine, breast cancer vaccine, recurrence A) Efficacy breast vaccine was performed. All searches were conducted between 15th The final analysis of phase 2b April 2019 to 20th September 2019. clinical trial of Nelipepimut-S plus 4 | P a g e TERHAD TERHAD GM-CSF with trastuzumab versus However, subanalysis of TNBC GM-CSF with trastuzumab to patients showed significant difference prevent recurrences in high risk, in median DFS in favour of the HER2 low-expressing breast intervention group [hazard ratio (HR) cancer was presented during 0.26 (95% Cl: 0.08,0.81)] for median ASCO-SITC Clinical Immuno- follow-up of 26.1 month Oncology Symposium in March (IQR:19.9,31.9).13 (See Figure 4) 2019. (NCT01570036).13 Patients in the intervention group (n=136) received vaccinations of NeuVax™ or GM-CSF intradermally every three weeks for six total vaccinations (primary vaccine series, PVS) starting with the third dose of trastuzumab maintenance therapy. Starting six months after the completion of the PVS, patients received four booster inoculations, one every six months for 30 month. The control group (n=139) received 24-month 36-month DFS (%) DFS (%) trastuzumab only. NeuVax + TZ 89.9 86.7 The intention to treat (ITT) analysis (N=136) showed significant reduction of recurrence among triple negative TZ (N=139) 83.8 80.8 breast cancer (TNBC) who received Figure 3: Disease-free survival among ITT NeuVax™ in combination with population trastuzumab (7.5%) as compared to trastuzumab alone (26.7%), p=0.01 There was no significant difference in the disease free survival (DFS) in the ITT analysis between the intervention
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