Delving into the Latest Updates on Pegfilgrastim biosimilar (Cinfa Biotech SL) with Synapse

Author: Timmerman, Ilse ; Zwaan, Christian M. ; Tissing, Wim J.E. ; Slager, Tirza J.E. ; Gelineau, Nina U. ; Dierselhuis, Miranda P. ; Voermans, Carlijn ; Westinga, Kasper ; van den Bos, Cor ; Kraal, Kathelijne C.J.M. ; Hochheuser, Caroline ; Zsiros, József ; Tytgat, Godelieve A.M. ; Kuijk, Carlijn ; Jaspers-Bakker, Antoinette ; Rozeman, Maria L. ; Fiocco, Marta ; Kunze, Nina

Autologous hematopoietic stem cell transplantation is used to restore bone marrow function after high-dose chemotherapy. For apheresis, granulocyte colony-stimulating factor (G-CSF) is standard of care, but obtaining sufficient stem cells can be challenging. Other mobilization agents include plerixafor and PEGylated G-CSF (PEG-G-CSF). While efficacy of these is established in adults, limited data for their use in pediatric patients are available. Here, we compare Good versus Poor Mobilizers and study success of different mobilization regimens in regard to CD34⁺cell-collection, -quality, -phenotype and hematologic reconstitution in pediatric patients. In this multi-center retrospective study, we analyzed data of 278 patients with solid tumors and lymphoma, mobilized with either G-CSF (n = 224), PEG-G-CSF (n = 34), or G-CSF/PEG-G-CSF with additional plerixafor (n = 20). In Poor Mobilizers (13.7% of all patients), addition of plerixafor to G-CSF augmented CD34⁺cell collection, without adverse effects on hematologic reconstitution and CD34⁺cell quality. PEG-G-CSF-aided mobilization was successful as first-line treatment in two-thirds of patients and did not impair hematological reconstitution, compared to G-CSF-only. Within the Poor Mobilizer group, G-CSF+plerixafor increased primitive (CD45RA^-CD38^-CD90⁺CD49f⁺) and CXCR4-expressing CD34⁺cells in apheresis products compared to G-CSF-only, without exceeding levels of Good Mobilizers. No plerixafor-related increase in tumor cells was observed in apheresis products. In conclusion, our comprehensive study supports the use of plerixafor and furthermore demonstrates the potential of patient-friendly PEG-G-CSF for mobilization of pediatric patients.

01 Dec 2024·Current Research in Translational Medicine

The transplantation effect of pegylated granulocyte colony-stimulating factor mobilized hematopoietic stem cells may be superior to that of G-CSF mobilized hematopoietic stem cells in haploidentical allogeneic hematopoietic cell transplantation

Article

Author: Lu, Ying ; Chen, Dong ; Cao, Junjie ; Du, Xiaohong ; Zhuang, Xianxu ; Liu, Xuhui ; Ye, Peipei ; Li, Shuangyue ; Pei, Renzhi

Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells have become the preferred source of hematopoietic stem cells. We compared the effectiveness of G-CSF and pegylated G-CSF (peg-G-CSF) for hematopoietic stem cell mobilization in haploidentical hematopoietic stem cell transplantation (haplo-HSCT) donors, and evaluated the transplant outcomes. We conducted a matched retrospective cohort study. Donors mobilized with peg-G-CSF (n = 70) and G-CSF (n = 70). 140 consecutive patients diagnosed with acute leukemia who underwent haplo-HSCT were included in this study. The findings revealed that the peg-G-CSF cohort exhibited significantly elevated myeloid-derived suppressor cells (MDSCs) levels in their grafts when compared to the G-CSF cohort (P < 0.001). The 100-day cumulative incidence (CI) of grade III-IV acute graft-versus-host disease (GVHD) and 1-year CI of moderate-to-severe chronic GVHD were 4.3% vs 14.3 % (P = 0.047) and 11.2% vs 27.4 % (P = 0.023), in the peg-G-CSF group and G-CSF group. Patients reveiving mobilized stem cell with peg-G-CSF had a significantly greater likelihood of 1-year GVHD-free relapse-free survival (GRFS) compared to patients reveiving mobilized stem cell with G-CSF (74.9% vs 37.9 %, P < 0.001). The higher graft MDSCs proportion was associated with lower grade II-IV aGVHD, cGVHD (P < 0.05) and higher GRFS in the univariate analysis (P < 0.05). Multivariate analysis showed that MDSCs proportion higher than 11.36 % (HR, 0.305; 95 % CI, 0.154-0.606; P = 0.001) and peg-G-CSF for stem cell mobilization (HR, 0.466; 95 % CI, 0.251-0.865; P = 0.016) were independent prognostic factors of GRFS. The superior survival rates observed in recipients of peg-G-CSF-mobilized cells are likely due to reduced acute GVHD, potentially mediated by the increased MDSCs within the grafts.

01 Oct 2023·JTO clinical and research reports

Docetaxel Plus Ramucirumab With Primary Prophylactic Pegylated Granulocyte-Colony Stimulating Factor Support for Elderly Patients With Advanced NSCLC: A Multicenter Prospective Single Arm Phase 2 Trial: DRAGON Study (WJOG9416L).

Article

Author: Tachihara, Motoko ; Takayama, Yusuke ; Watanabe, Hiroshi ; Okada, Hideaki ; Ota, Keiichi ; Toyozawa, Ryo ; Sato, Yuki ; Shimokawa, Mototsugu ; Nakamura, Atsushi ; Nakagawa, Kazuhiko ; Yamamoto, Nobuyuki ; Miura, Satoru ; Wakuda, Kazushige ; Hata, Akito ; Hara, Satoshi ; Tabata, Eriko ; Tokito, Takaaki

Introduction:

Docetaxel plus ramucirumab could be a promising treatment for chemo-naive elderly patients with NSCLC, but high incidence of febrile neutropenia (FN) is a critical concern. We thus adopted a routine primary prophylactic pegylated-granulocyte-colony stimulating factor (PEG-G-CSF) to reduce FN and maximize the efficacy of docetaxel plus ramucirumab in elderly patients.

Methods:

This is a single arm phase 2 trial for chemo-naive elderly patients (aged ≥75 y) with advanced NSCLC. Docetaxel (60 mg/m², d 1) plus ramucirumab (10 mg/kg, d 1) with PEG-G-CSF (3.6 mg, d 2) was administered every 3 weeks until progression. The primary end point was overall response rate (ORR) (expected ORR: 35%).

Results:

Between February 2018 and January 2021, 54 patients were enrolled. Median age was 78 (range: 75-86). A total of 21 (38.9%) partial response, 22 (40.7%) stable disease, nine (16.7%) progressive disease, and two (3.7%) not assessable were confirmed, resulting in ORR of 38.9% (90% confidence interval [CI]: 27.7%-51.0%) and disease control rate of 79.6%. Median progression-free survival and overall survival were 5.2 (95% CI: 4.2-6.9) and 12.7 (95% CI: 10.2-18.9) months, respectively. There were one (1.9%) FN, two (3.7%) bleeding grade greater than or equal to 3, and one (1.9%) treatment-related death (pneumonitis). Pneumonitis occurred in five patients (9.3%). Main adverse events grade greater than or equal to 3 were observed: four (7%) thrombocytopenia; three (5.6%) neutropenia; six (11.1%) hyposodium; five (9.3%) infection; five (9.3%) hypertension; four (7.4%) anorexia; and three (5.6%) oral mucositis.

Conclusions:

Docetaxel plus ramucirumab with PEG-G-CSF revealed efficacy and safety for chemo-naive elderly patients with NSCLC. Primary prophylactic PEG-G-CSF highly prevented FN.

1

News (Medical) associated with Pegfilgrastim biosimilar (Cinfa Biotech SL)

22 Sep 2018

·www.biospace.com

Cinfa Biotech receives positive CHMP opinion for Pelmeg® (pegfilgrastim), a proposed biosimilar to Neulasta®

Cinfa Biotech today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Pelmeg® (B12019) Munich, Germany, 21 September 2018 – The biosimilar company Cinfa Biotech today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Pelmeg ® (B12019), a proposed biosimilar to Neulasta ® (pegfilgrastim), for the treatment of chemotherapy-induced neutropenia. “The positive CHMP opinion for our proposed pegfilgrastim biosimilar product Pelmeg ® is an important milestone in our effort to provide patients with high-quality and affordable treatment options,” said Dr. Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH. “This recommendation reflects the high quality of our data and validates our approach for the further development of our product pipeline. ” The marketing authorization application was submitted in September 2017 and is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing Pelmeg ® and Neulasta ® . The clinical development program included two studies, which confirmed the analytical and biofunctional similarity of Pelmeg ® and Neulasta ® in highly sensitive clinical study settings. The European Commission (EC) will review the CHMP’s positive opinion. If adopted, the EC will grant a centralized marketing authorization, which will be valid in all member countries of the EU. About Cinfa Biotech Cinfa Biotech has offices in Munich, Germany and Pamplona, Spain. Founded in 2013, the Company is creating a pipeline of biosimilar drugs for a range of indications to address the growing need for affordable therapies based on proven science, quality, safety and efficacy. A complete team of experts with decades of in-depth experience is conducting product development, clinical studies, manufacturing and quality control, according to the highest European standards. Cinfa Biotech’s first product candidate is Pelmeg ® (B12019), a biosimilar version of Neulasta ® (pegfilgrastim). For more information, please visit: Neulasta ® is a registered trademark of Amgen, Inc. Pelmeg ® is a registered trademark of Cinfa Biotech. Contact: Cinfa Biotech GmbH Nymphenburger Strasse 3c 80335 Munich, Germany Phone +49 89 54 54 62 0 Email: info[at]cinfabiotech.com For press enquiries: MC Services AG Julia von Hummel, Shaun Brown Phone: +49 89 210 228-0 Email: cinfabiotech[at]mc-services.eu

Drug ApprovalAccelerated Approval

100 Deals associated with Pegfilgrastim biosimilar (Cinfa Biotech SL)

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D06889	-	L03AA13	-

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Indication	Country/Location	Organization	Date
Febrile Neutropenia	European Union	Mundipharma International Ltd.	20 Nov 2018
Febrile Neutropenia	Iceland	Mundipharma International Ltd.	20 Nov 2018
Febrile Neutropenia	Liechtenstein	Mundipharma International Ltd.	20 Nov 2018
Febrile Neutropenia	Norway	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	European Union	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	Iceland	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	Liechtenstein	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	Norway	Mundipharma International Ltd.	20 Nov 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-UMIN000030598 (DRAGON study: WJOG9416L, ESMO2022)	Phase 2	Non-Small Cell Lung Cancer	54	DOcetaxel (DOC) plus RAmucirumab (RAM) with pegylated Granulocyte-colONy stimulating factor (PEG-G-CSF)	usvxjlrxpd(tmucscxuur) = vmkszaptik lmffbhpdid (exrnggpzzk, 27.7 - 51.0) View more	-	10 Sep 2022
ESMO2018	Phase 2	Non-Small Cell Lung Cancer	-	Docetaxel plus ramucirumab with primary prophylactic PEG-G-CSF	nzsdxqtnhl(xkraizvswa) = erzkuaoviq xprqkybnif (imkrdddtij ) View more	Positive	20 Oct 2018
ESMO2018	Phase 2	Non-Small Cell Lung Cancer	-	Docetaxel monotherapy	jgqpkznclu(lyfadpzlpn) = aheeurlbor uaofwrgrlr (uzcwjivhii )	Positive	20 Oct 2018

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