Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap - LARVOL DELTA

Bevacizumab, olaparib, and durvalumab in patients with relapsed ovarian cancer: a phase II clinical trial from the GINECO group. (PubMed, Nat Commun) - P2 | "Patients were treated with olaparib (300 mg orally, twice daily), the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), and durvalumab (1.12 g intravenously, once-every-3-weeks) in nine French centers. No toxic deaths or major safety signals were observed. Here we show that further investigation of this triple combination may be considered in AOC patients with platinum-resistant relapse."

Journal • P2 data • Oncology • Ovarian Cancer • Solid Tumor

Pharmacokinetics, safety, tolerability, and immunogenicity of FKB238, a new biosimilar of bevacizumab, in healthy participants. (PubMed, Int J Clin Pharmacol Ther) - "The study demonstrated the PK similarity of FKB238 to both EU-bevacizumab and US-bevacizumab after a single intravenous infusion. FKB238 was well tolerated in healthy participants, and there was no difference in ADA incidence among the 3 products."

Clinical • Journal • PK/PD data

Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=731 | Completed | Sponsor: Centus Biotherapeutics Limited | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BOLD: Tri Association in Patient With Advanced Epithelial Ovarian Cancer in Relapse (clinicaltrials.gov) - P2; N=74; Active, not recruiting; Sponsor: ARCAGY/ GINECO GROUP; Trial completion date: Apr 2024 ➔ Jan 2024

Clinical • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA • MRI • MUC16

[VIRTUAL] Efficacy and safety of bevacizumab biosimilar FKB238 versus originator bevacizumab: Results from a phase III trial in patients with non-squamous non-small cell lung cancer (NS-NSCLC). (ASCO 2020) - P3 | "All patients received IV infusions of paclitaxel (200 mg/m2) and carboplatin (AUC 6.0) immediately prior to investigational drugs for 4-6 cycles. There were no meaningful differences in efficacy and safety between FKB238 or o-bev in patients with NS-NSCLC. ORR efficacy equivalence was demonstrated, and the safety profiles of both drugs were similar. Research Funding: Centus Biotherapeutics Ltd"

Clinical • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Centus Bevacizumab Candidate Demonstrates Equivalence in Phase 3 Study (Center for Biosimilars) - P3, N=731; AVANA (NCT02810457); Sponsor: Centus Biotherapeutics Limited; "The ORR rate was 51.6% in the FKB238 arm (n = 364) and 53.7% in the RP arm (n = 367). Estimated median progression-free survival (PFS) was 7.72 months in the FKB238 arm vs 7.62 months for the RP group (HR, 0.97; 95% CI, 0.82-1.16)...The occurrence of treatment-emergent adverse events (TEAEs) for patients receiving FKB238 vs RP was 94.2% and 95.1%, respectively. Investigators said 53.6% and 55.5% of patients in the FKB238 and originator arms experienced grade 3 or higher TEAEs, respectively."

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

FKB238: A Bevacizumab Biosimilar. (PubMed, Clin Drug Investig) - "FKB238 has similar physicochemical and pharmacodynamic properties to those of reference bevacizumab and pharmacokinetic similarity was shown in healthy volunteers and in patients with non-small cell lung cancer (NSCLC). FKB238 demonstrated equivalent clinical efficacy to reference bevacizumab in patients with advanced or recurrent nonsquamous NSCLC, with similar tolerability, safety and immunogenicity profiles."

Journal • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC). (PubMed, BioDrugs) - P3 | "Efficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC."

Clinical • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Genentech and Centus Settle Bevacizumab Litigation (JD Supra) - "...the parties filed a Joint Motion to Stay All Deadlines and Notice of Settlement. The motion states that “[a]ll matters in controversy between the parties have been settled, in principle, and Genentech and Centus are in the process of preparing settlement documents.” The motion further states that the parties anticipate filing dismissal papers within 30 days."

Corporate lawsuit • Oncology

AstraZeneca-Backed JV Sued By Genentech Over Avastin Biosimilar (Generics Bulletin - Informa) - "With the US biosimilar Avastin market now more than a year old, another potential player, Centus Biotherapeutics, finds itself facing trial over its biosimilar candidate. The UK-based joint venture already boasts approval from the European Commission for its FKB238 product, Equidacent."

Corporate lawsuit • Oncology

Equidacent: “The Committee adopted a positive opinion recommending the granting of a marketing authorization by consensus together with the CHMP assessment report and translation timetable [Solid tumors]” (European Medicines Agency) - CHMP Final Minutes of the meeting on 20-23 Jul 2020

European regulatory • Breast Cancer • Colon Cancer • Ovarian Cancer

Centus Biotherapeutics Receives European Marketing Authorization For Equidacent, Biosimilar Avastin (PipelineReview) - "Centus Biotherapeutics...announced that the European Commission (EC) has granted the marketing authorization for Equidacent® (Product Code: FKB238), the company's biosimilar to Avastin® (bevacizumab)....Equidacent® is indicated for the following indications: metastatic carcinoma of the colon or rectum; metastatic breast cancer; unresectable advanced, metastatic, or recurrent non-small cell lung cancer; advanced and/or metastatic renal cell cancer; epithelial ovarian, fallopian tube, or primary peritoneal cancer; persistent, recurrent, or metastatic carcinoma of the cervix."

European regulatory • Breast Cancer • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

"#CentusBiotherapeutics Receives #EuropeanMarketing Authorization for #Equidacent®, Biosimilar #Avastin® https://t.co/VumLQV6Z4v" (@1stOncology)

Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer (clinicaltrials.gov) - P3; N=500; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Aug 2011 ➔ Jun 2019

Trial primary completion date • Biosimilar • Bladder Cancer • Hematological Malignancies • Prostate Cancer • Reperfusion Injury • Urethral Cancer

Centus Biotherapeutics Announces Positive CHMP Opinion for FKB238, Biosimilar Bevacizumab (Fujifilm Kyowa Kirin Biologics Press Release) - "Centus Biotherapeutics...announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of EquidacentTM (Product Code: FKB238), the company’s biosimilar to Avastin® (bevacizumab), for indications including metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, persistent, recurrent, or metastatic carcinoma of the cervix. The decision of the European Commission (EC) on the approval is expected in September 2020..."

European regulatory • Breast Cancer • Colon Cancer • Fallopian Tube Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

A randomized, double-blind, single dose comparison of pharmacokinetics and safety of FKB238 with bevacizumab. (ASCO 2017) - "The study demonstrated PK similarity of FKB238, EU Avastin and US Avastin in healthy male subjects. FKB238 was well tolerated, with no serious AEs. All three study compounds showed comparable safety profile with no significant AEs or evidence of a propensity to form ADAs."

Clinical • Biosimilar • Colorectal Cancer

Kyowa Hakko Kirin: Q2 FY 2014 Results (Kyowa Hakko Kirin Pharma) - Anticipated initiation of P1 trial in 2014

Anticipated new P1 trial • Biosimilar

Kyowa Hakko Kirin: Mid-term Business Plan (Kyowa Hakko Kirin Pharma) - Anticipated approval in UK in 2016-2020

Anticipated EU regulatory • Biosimilar

Kyowa Hakko Kirin: Q3 FY 2013 Results (Kyowa Hakko Kirin Pharma) - Anticipated initiation of new trial for cancer in 2014

Anticipated new trial • Biosimilar • Colorectal Cancer

BOLD: Tri Association in Patient With Advanced Epithelial Ovarian Cancer in Relapse (clinicaltrials.gov) - P2; N=74; Active, not recruiting; Sponsor: ARCAGY/ GINECO GROUP; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Cardiovascular • Gastrointestinal Cancer • Genetic Disorders • Gynecologic Cancers • Hematological Disorders • Hemophilia • Immunology • Inflammation • Inflammatory Arthritis • Oncology • Ovarian Cancer • Reperfusion Injury • Rheumatoid Arthritis • Rheumatology • Solid Tumor

Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P3; N=731; Active, not recruiting; Sponsor: Centus Biotherapeutics Limited; Trial completion date: Jun 2019 ➔ Feb 2022; Initiation date: Jun 2016 ➔ Sep 2016; Trial primary completion date: Jun 2019 ➔ Jan 2019

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov) - P2; N=88; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Sep 2016 ➔ Mar 2017

Trial primary completion date