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Antibody-Based Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
The most common side effects of enfortumab vedotin-ejfv are fatigue, peripheral neuropathy (nerve damage resulting in tingling or numbness), decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eyes, pruritis (itching), and dry skin.
Real-World Evidence for Coverage and Payment Decisions
Published in Harry Yang, Binbing Yu, Real-World Evidence in Drug Development and Evaluation, 2021
Saurabh Aggarwal, Hui Huang, Ozlem Topaloglu, Ross Selby, Hui Huang, Saurabh (Rob) Aggarwal
More payers and other stakeholders are increasingly demanding evidence for a product's effectiveness in their coverage populations. Studies to generate this evidence can be conducted either by the product manufacturer, or payer, or as a joint collaboration from multiple stakeholders. A real-world study by Takeda Pharmaceuticals in Germany and the United Kingdom showed that brentuximab vedotin is effective in autologous stem cell transplant (ASCT)-ineligible patients with relapsed/refractory Hodgkin lymphoma (rrHL)21. Kaiser Permanente Northern California has a viral hepatitis registry that includes administrative and clinical data for all patients with chronic hepatitis C22. Recently, many new joint collaborations between a product manufacturer and a payer/HTA were announced to align reimbursement to real-world outcomes in the payer/HTA's target population. For example, Merck and United Health's Optum have an initiative that involves the use of real-world data to co-develop and test advanced predictive models and co-design an outcome-based risk sharing agreement to reduce clinical and financial uncertainty23.
Current and Future Perspectives of Marine Drugs for Cancer Disorders: A Critical Review
Published in Rohit Dutt, Anil K. Sharma, Raj K. Keservani, Vandana Garg, Promising Drug Molecules of Natural Origin, 2020
Bhaskaran Mahendran, Thirumalaraju Vaishnavi, Vishakante Gowda, Johurul Islam, Narahari Rishitha, Arunachalam Muthuraman, Rajavel Varatharajan
Various marine drugs are identified to treat multiple life-threatening disorders. Currently, the FDA approved the various marine-derived products to treats cancer disorders. Such agents are eribulin mesylate (used for metastatic breast cancer), cytarabine (treatment of leukemia), brentuximab vedotin (used for anaplastic T-cell malignant lymphoma and Hodgkin’s lymphoma), and trabectidine (treatment of ovarian cancer and soft tissue sarcoma) (Grignani et al., 2018; Fleeman et al., 2019; Sandoval-Sus et al., 2019). Furthermore, marine-derived products are documented to produce the multi-targeted action on cancer cells by more potent and efficacy. In addition, around 1500 natural molecules are isolated from marine origin, and tested for their potency with various in-vivo biological screening methods. Moreover, these marine resources are also showing promising role in the management of cancer cell proliferation (Fleeman et al., 2019). Marine drugs have potent anticancer property via inhibition of inflammatory signaling pathway, i.e., NF-κB, phosphorylation of p65 and inhibitory kappa B (IκB) in breast cancer cells and leukemia. Some of the marine products regulate the topoisomerase-I activity, pro-angiogenic actions, and epidermal growth factor receptor (EGFR) protein expression. These are the major target for the development of human cancer cell proliferation (Dyshlovoy and Honecker, 2018; Malve 2016). Hence, the marine drugs based discovery of newer molecules is important to treat multiple cancer cell proliferation.
Ladiratuzumab vedotin for metastatic triple negative cancer: preliminary results, key challenges, and clinical potential
Published in Expert Opinion on Investigational Drugs, 2022
Alessandro Rizzo, Antonio Cusmai, Silvana Acquafredda, Lucia Rinaldi, Gennaro Palmiotti
Following preclinical evidence supporting the activity of this ADC, ladiratuzumab vedotin has been assessed in the phase I, multi-part, dose-escalation SGNLVA-001 trial [9]. Eligible subjects included two patient populations: 1) patients with first- or second-line endocrine therapy refractory hormone receptor-positive/HER2-negative metastatic breast cancer; 2) patients with second-line refractory metastatic triple-negative breast cancer [9]. No LIV-1 expression requirement was necessary for the study. According to the preliminary results of this study, overall response rate (ORR) and disease control rate (DCR) were 32% and 64%, respectively, among patients with metastatic triple-negative breast cancer, with a median progression-free survival (PFS) of 11.3 weeks. The majority of treatment-related adverse events were grade 1 or 2, the most commonly of which included fatigue (59%), nausea (51%), peripheral neuropathy (44%), and alopecia (36%). Two patients experienced febrile neutropenia, and one treatment-related death was reported; treatment discontinuation due to adverse events was observed in seven subjects. The updated results of this trial have been recently presented by Tsai and colleagues [10]. In second-line refractory triple negative breast cancer patients, ladiratuzumab vedotin at a dose of 1.25 mg/kg showed an ORR of 28%, confirming the promising activity of this agent.
Antibody–drug conjugates for previously treated aggressive lymphomas: focus on polatuzumab vedotin
Published in Expert Review of Clinical Pharmacology, 2020
J. M. Burke, F. Morschhauser, D. Andorsky, C. Lee, J. P. Sharman
Polatuzumab vedotin combines a highly cytotoxic payload with antibody-mediated antitumor effects, and the cleavable linker provides efficient drug delivery. The design advantages of this ADC are demonstrated by its clinical efficacy and favorable safety profile in patients with previously-untreated first-line and R/R DLBCL and in R/R FL. In the phase II randomized study of pola-BR versus BR in patients with transplant-ineligible R/R DLBCL (GO29365; NCT02257567), pola-BR was associated with a significantly higher CR rate, and improved PFS and OS compared with BR alone [60]. The CR rate supported the US FDA approval of pola-BR for patients with R/R DLBCL after at least two prior therapies [20]. It also supported the European Commission conditional marketing authorization of pola-BR in patients with transplant-ineligible R/R DLBCL [66]. The phase Ib/II study (GO29044; NCT01992653) of pola plus R-/G-CHP showed promising efficacy outcomes and an acceptable profile, which informed the phase III POLARIX study (NCT03274492) of polatuzumab vedotin plus R-CHP versus R-CHOP.
Enfortumab Vedotin, a fully human monoclonal antibody against Nectin 4 conjugated to monomethyl auristatin E for metastatic urothelial Carcinoma
Published in Expert Opinion on Investigational Drugs, 2019
Bradley A McGregor, Guru Sonpavde
Following platinum therapy and PD1/PDL1 checkpoint inhibition, systemic therapeutic options for metastatic urothelial carcinoma are limited for a majority of patients. Erdafitinib is an excellent option for post-platinum patients (with or without PD1/PDL1 inhibitor exposure) with an activating mutation in FGFR3/2 though unfortunately this remains a minority of patients. Enfortumab vedotin is a well-tolerated drug with impressive efficacy in unselected patients with heavily treated urothelial carcinoma. The response rate of 44% with CR rate of 9% and median OS of nearly 1 year [24] is unprecedented and rivals responses seen with cisplatin-based combination chemotherapy in the front line setting [2,4]. The activity in patients with liver metastases is particularly noteworthy given the generally poor prognosis in these patients.