Kanjinti (trastuzumab-anns) / Amgen, Daiichi Sankyo, AbbVie - LARVOL DELTA

Variation in Provider Reimbursement for Biosimilars and Reference Biologics by Commercial Health Plans (ISPOR 2025) - "Using price data published by payers, we explored the variation in reimbursement across large payers for two biologic drugs and their biosimilars in two large metropolitan areas. We used price data from Q1 2024 for three largest payers in San Francisco and Chicago areas, each for Herceptin (trastuzumab) and its biosimilars (Ontruzant, Herzuma, Ogivri, Trazimera, and Kanjinti). Drivers of reimbursement rates include terms of confidential contracts between manufacturers, payers, and providers, and incentives for providers to use less expensive biosimilars. Payer price transparency data offer a unique opportunity to understand how reimbursement incentivizes providers. It may be used to explore the impact of biosimilar competition on spending on trastuzumab products across commercial markets."

HEOR • Reimbursement • US reimbursement

Cost-Efficiency Modeling of Conversion to Biosimilar Trastuzumab-qyyp in Early-Stage Breast Cancer in Medicare (ISPOR 2025) - "OBJECTIVES: Biosimilars to originator trastuzumab (Herceptin®), such as trastuzumab-qyyp (Trazimera™), can deliver substantial savings and/or expanded access to biologic therapies for patients with early-stage breast cancer (BC)...We modeled combination therapy with docetaxel, carboplatin, and trastuzumab (TCH), using costs derived from 2024 Average Sales Price (ASP)...These savings represent 41% and 82% reductions in cost vs. originator-based treatment, respectively, and exceeded savings from alternative biosimilars trastuzumab-anns, -dttb, -pkrb, and -dkst. TCH with trastuzumab-qyyp can achieve substantial cost savings relative to originator-based treatment, allowing reinvestment to treat a substantial number of additional patients with early-stage BC, or fund other costs of care in Medicare, on a budget-neutral basis."

Medicare • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Pertuzumab and Trastuzumab Biosimilars in Real-Life Association for the First-Line Treatment of HER2-Positive Metastatic Breast Cancer: the prospective, observational PETRA study (SABCS 2024) - "TBs used were Trazimera® in 39 patients (34.8%), Ontruzant® in 27 (24.1%), Herzuma® in 23 (20.5%), Ogivri® in 19 (17.0%), and Kanjinti® in 4 (3.6%). The majority of chemotherapy regimens were paclitaxel in 90 patients (80.4%), followed by docetaxel in 18 (16.1%) and vinorelbine in 4 (3.6%)... Trastuzumab biosimilars appear to be similar to Herceptin when combined with pertuzumab and chemotherapy in the first-line treatment of metastatic HER2-positive breast cancer. However, 13% of patients experienced a decrease in LVEF during follow-up, which is significant. Systematic and regular monitoring of cardiac toxicity is mandatory."

Clinical • Metastases • Observational data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Contemporary patterns of Medicare Utilization and Spending on Herceptin and its Biosimilars in Breast Cancer. (SABCS 2024) - "The six FDA approved Herceptin biosimilars are: Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, and Hercessi. There has been a significant decline in Herceptin utilization and spending, accompanied by a shift towards biosimilars; reflecting changing trends in HER2-positive breast cancer treatments. Kanjinti and Trazimera, in particular, experienced substantial increases in spending, dosage units, claims, and beneficiaries, indicating growing acceptance and usage. Despite these increases, total spending and claims for Herceptin remain higher than for its biosimilars."

Medicare • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Utilization and patient characteristics for the trastuzumab reference and biosimilars, and other human epidermal growth factor receptor 2 inhibitors in the United States. (PubMed, J Manag Care Spec Pharm) - "The proportion of total incident episodes of the reference trastuzumab decreased substantially over time (96% in 2016 vs 28% in 2021) as utilization of the biosimilars increased (eg, use of trastuzumab-anns increased from 2% [2019] to 36% [2021]). Trastuzumab biosimilars utilization has grown since their introduction to the US market. Exploration of these biosimilars' comparative effectiveness and safety to their reference product is warranted."

Journal • Breast Cancer • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Oncology • Solid Tumor • HER-2

Comparison of trastuzumab biosimilar ABP 980 with reference trastuzumab in neoadjuvant therapy of HER2-positive breast cancer – analysis of a large university breast cancer center (DGS 2024) - "Summary Background ABP 980 is a biosimilar antibody of reference trastuzumab (RTZ). For patients treated with ABP 980 as compared to RTZ, there was no significant difference regarding efficacy (pCR-rates of 60.9% versus 62.8%, p = 0.829) or cardiac safety (LVEF decline in 6.5% versus 2.6%, p = 0.274). Conclusion Similarity of ABP 980 as compared to RTZ was confirmed in a real-world situation, including a large proportion of patients that have also received pertuzumab treatment."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab biosimilars interchangeability: Preliminary real-world data in neoadjuvant breast cancer setting. (ASCO 2024) - " Along the studied period, SUS had offered 3 T biosimilars: ABP 980 (Amgen), CT-P6 (Celltrion), SB3 (Samsung), plus reference trastuzumab (Roche). The standard regimen was ACq21 4cycles followed by Taxane (Docetaxel q21 or weekly Paclitaxel) plus T 4cycles... Although IC among biosimilars compound had been globally accepted, it was not clinically fully tested. Brazilian Ministry of Health, as the only provider, has a policy based on lowest cost for trastuzumab compound, causing constant changes along pts treatments. Furthermore, it is expected that Brazil has the potential to evaluate the IC in thousands of pts prospectively next years."

Clinical • Real-world • Real-world evidence • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Denosumab added to 2 different nab-paclitaxel regimens as neoadjuvant therapy in patients with primary breast cancer: Time to event analysis from the GeparX 2 × 2 randomized clinical trial (ESMO-BC 2024) - P2 | "Pts with TNBC received additional carboplatin, and pts with HER2+ BC received trastuzumab biosimilar ABP980 for 8 cycles and pertuzumab for at least 4 cycles. All pts subsequently received standard epirubicin/cyclophosphamide for 4 cycles...Although there were numerically less distant relapses with Dmab, this did not reach statistical significance. Despite the observed increase in pCR with nabP weekly, this did not translate into an improved long-term outcome."

Clinical • Late-breaking abstract • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Trastuzumab biosimilar (TB) in combination with pertuzumab (P) and chemotherapy (ct) in HER2 positive, metastatic breast cancer (mBC): Efficacy and safety (ESMO-BC 2024) - "TB was TRAZIMERA® in 38 pts (34.5 %), ONTRUZANT® in 26 (23.6 %), HERZUMA® in 23 (20.9 %), OGIVRI® in 19 (17.3%) and KANJINTI® in 4 (3.6 %). Chemotherapy was weekly paclitaxel in 80.0 % of pts, docetaxel in 16.4 %, vinorelbine in 3.6 %...Two pts experienced grade 3 and 4 CHF, respectively. Conclusions Efficacy and tolerance of TB appears comparable to HERCEPTIN in the metastatic setting, as reported in previous clinical trials."

Clinical • Combination therapy • Metastases • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Interstitial Lung Disease • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database. (PubMed, Expert Opin Drug Saf) - "Significant AE reporting signals were identified: 1) death for biological rituximab, pruritus for biosimilar rituximab-pvvr, and infusion related reaction for biological rituximab and biosimilar rituximab-pvvr (significantly higher ROR for rituximab-pvvr than biological rituximab, p < .0001); 2) death for biological bevacizumab and biosimilar bevacizumab-bvzr (significantly higher ROR for bevacizumab-bvzr than biological bevacizumab, p < .0001), hypertension, platelet count decreased (PCD), and proteinuria for biological bevacizumab and biosimilar bevacizumab-awwb (significantly higher ROR of PCD for bevacizumab-awwb than originator bevacizumab, p = .001); and 3) rash for biosimilar trastuzumab-anns. Findings call for large, longitudinal studies to examine causality of certain AEs with rituximab-pvvr and bevacizumab biosimilars."

Adverse events • Journal • Cardiovascular • Dermatology • Hypertension • Oncology • Pruritus • Renal Disease

Trastuzumab biosimilars (kanjinti) efficacy in breast cancer: Case report in Saudi Arabia (EUROBIOSIMILARS 2024) - No abstract available

Case report • Clinical • Breast Cancer • Oncology • Solid Tumor

Trastuzumab biosimilars (kanjinti) efficacy in breast cancer: Case report in Saudi Arabia (EUROBIOSIMILARS 2024) - No abstract available

Case report • Clinical • Breast Cancer • Oncology • Solid Tumor

Biosimilar in Breast Cancer: A Narrative Review. (PubMed, Cureus) - "Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world clinical scenarios during introduction of trastuzumab biosimilar for HER2-positive breast cancer in the European Union. (PubMed, Future Oncol) - "Common reasons for trastuzumab-anns discontinuation were a switch to another biosimilar product (34.8%, n = 85) or to trastuzumab reference product (15.6%, n = 38). Trastuzumab-anns was widely used in various treatment settings for HER2+ breast cancer."

Journal • Real-world • Real-world evidence • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS (PRNewswire) - "MVASI (bevacizumab-awwb) sales decreased 8% year-over-year for the fourth quarter, primarily driven by lower net selling price, partially offset by 12% volume growth. Full year sales decreased 11%, primarily driven by lower net selling price, partially offset by 13% volume growth. Going forward, we expect continued net selling price erosion driven by increased competition. KANJINTI (trastuzumab-anns) sales decreased 33% year-over-year for the fourth quarter and 50% for the full year, driven by lower net selling price and volume decline."

Sales • Cervical Cancer • Colorectal Cancer • Glioblastoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

Germline mutation status of BRCA1/2 and other breast cancer predisposition genes as predictive and prognostic biomarker: Results of the GeparX study (GeparX-BRCA) (SABCS 2023) - "The trial randomized 780 patients twice to a total of 4 treatment groups (to receive or not receive denosumab; to receive nab-paclitaxel 125 mg/m2 weekly for 12 weeks or days 1 and 8 every 3 weeks for 4 cycles, both followed by 4 cycles of epirubicin/cyclophosphamide, 90/600 mg/m2 every 2 weeks/every 3 weeks according to the investigator´s choice). Carboplatin was given in triple-negative breast cancer (TNBC), and trastuzumab biosimilar ABP980 plus pertuzumab was given in human epidermal growth factor-2-positive (HER2+) BC... Irrespective of the treatment arm, higher pCR rates were observed in BRCA1/2 mutations carriers vs non-carriers. Both BRCA1/2 mutation carriers and non-carriers benefitted most from weekly nab-paclitaxel. No pronounced effect was observed for denosumab in either group."

Biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • HER-2

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis. (PubMed, Immunopharmacol Immunotoxicol) - "The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3...Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients."

Journal • Retrospective data • Review • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Effect of Denosumab Added to 2 Different nab-Paclitaxel Regimens as Neoadjuvant Therapy in Patients With Primary Breast Cancer: The GeparX 2 × 2 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "Patients were randomized to receive or not receive denosumab, 120 mg subcutaneously every 4 weeks for 6 cycles, and either nab-paclitaxel, 125 mg/m2 weekly for 12 weeks or days 1 and 8 every 3 weeks for 4 cycles (8 doses), followed by 4 cycles of epirubicin/cyclophosphamide, 90/600 mg/m2 (every 2 weeks or every 3 weeks). Carboplatin was given in triple-negative BC (TNBC), and trastuzumab biosimilar ABP980 plus pertuzumab was given in ERBB2-positive BC (ERBB2-positive substudy)...Nab-paclitaxel at a dosage of 125 mg/m2 weekly significantly increased the pCR rate compared with the days 1 and 8, every-3-weeks schedule overall and in TNBC, but generated higher toxicity. ClinicalTrials.gov Identifier: NCT02682693."

Clinical • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

Comparison of Biosimilar Trastuzumab ABP 980 with Reference Trastuzumab in Neoadjuvant Therapy for HER2-positive Breast Cancer - an Analysis of a Large University Breast Cancer Centre. (PubMed, Geburtshilfe Frauenheilkd) - "Background ABP 980 is a biosimilar antibody to reference trastuzumab (RTZ). For patients treated with ABP 980 as compared to RTZ, there was no significant difference regarding efficacy (pCR-rates of 60.9% versus 62.8%, p = 0.829) or cardiac safety (LVEF decline in 6.5% versus 2.6%, p = 0.274). Conclusion Similarity of ABP 980 as compared to RTZ was confirmed in a real-world situation, including a large proportion of patients that have also received pertuzumab treatment."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Women's Health • HER-2

AMGEN REPORTS FIRST QUARTER FINANCIAL RESULTS (PRNewswire) - "MVASI® (bevacizumab-awwb) sales decreased 17% year-over-year for the first quarter, driven by lower net selling price, partially offset by 15% volume growth; KANJINTI® (trastuzumab-anns) sales decreased 51% year-over-year for the first quarter, driven by lower net selling price and volume. The published first quarter ASP for KANJINTI in the U.S. declined 36% year-over-year and increased 3% quarter-over-quarter."

Sales • Oncology • Solid Tumor

Safety results from a randomized, double-blind, phase 3 study of ABP 980 compared with trastuzumab in patients with breast cancer (SABCS 2017) - "After run-in anthracycline-based chemotherapy, patients were randomized 1:1 to intravenous ABP 980 or TRAS plus paclitaxel Q3W for 4 cycles. Safety of ABP 980 is similar to TRAS in patients with HER2+ early breast cancer in both the neoadjuvant and adjuvant phases and consistent with the historical safety profile of TRAS. The immunogenicity profile of ABP 980 is low and consistent with TRAS."

Clinical • P3 data • HER2 Breast Cancer

Efficacy and safety of biosimilar ABP 980 compared with trastuzumab in HER2 positive early breast cancer (ESMO 2017) - "After run-in anthracycline-based chemotherapy, patients were randomized 1:1 to intravenous ABP 980 or TRAS plus paclitaxel Q3W for 4 cycles. Results of this study show clinical equivalence of ABP 980 and TRAS in the neoadjuvant setting and add to the totality of evidence demonstrating similarity between ABP 980 and TRAS."

Clinical • HER2 Breast Cancer

Combined biomarker analysis for prediction of pathological complete response (pCR) after 12 weeks of pembrolizumab + trastuzumab + pertuzumab in HER2-enriched early breast cancer: Keyriched-1 trial (SABCS 2022) - P2 | "All patients received 4 cycles of pembrolizumab (200 mg), trastuzumab biosimilar ABP 980 (loading dose (LD) 8 mg/kg bodyweight (BW), maintenance dose (MD) 6 mg/kg BW), and pertuzumab (LD 840 mg/kg BW, MD 420 mg/kg BW) q21d. Conclusions Biomarker analysis in the unique KEYRICHED-1 cohort revealed that early response at week 3, ERBB2 and immune related signatures as well as on-therapy sTIL levels predict pCR after a chemotherapy-free combination of immunotherapy and dual HER2 blockade in HER2-enriched EBC. These results pave the way for validation in larger de- escalation trials investigating short, chemotherapy-free regimens in selected patients with HER2+ EBC."

Biomarker • Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CD20 • CD4 • CD68 • CD8 • HER-2 • IDO1 • IFNG • PD-1 • PD-L1 • TIGIT

Cardiac safety of the trastuzumab biosimilar ABP 980 in women with HER2-positive early breast cancer in the LILAC study (ESGO 2019) - "The incidence of LVEF decline was consistent with the known cardiac safety profile of the RP. No new cardiac safety signals were observed whether patients were on ABP 980 or switched from RP to ABP 980."

Clinical • Breast Cancer • Cardiovascular • Congestive Heart Failure • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

"Biosimilar Pricing Policy Challenges Underscored By Amgen Mvasi, Kanjinti Sales Declines https://t.co/UYxYftm6Yy #PinkSheet" (@PharmaPinkSheet)

Pricing