Article
Hematology
Mehdi Hamadani, Graham P. Collins, Paolo F. Caimi, Felipe Samaniego, Alexander Spira, Andrew Davies, John Radford, Tobias Menne, Anand Karnad, Jasmine M. Zain, Paul Fields, Karin Havenith, Hans G. Cruz, Shui He, Joseph Boni, Jay Feingold, Jens Wuerthner, Steven Horwitz
Summary: This study evaluated a novel anti-CD25 antibody-drug conjugate in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma, showing potential efficacy in classical Hodgkin lymphoma and overall antitumour activity. The drug demonstrated good safety profile in the patient population studied.
LANCET HAEMATOLOGY
(2021)
Article
Oncology
Paolo F. Caimi, Weiyun Ai, Juan Pablo Alderuccio, Kirit M. Ardeshna, Mehdi Hamadani, Brian Hess, Brad S. Kahl, John Radford, Melhem Solh, Anastasios Stathis, Pier Luigi Zinzani, Karin Havenith, Jay Feingold, Shui He, Yajuan Qin, David Ungar, Xiaoyan Zhang, Carmelo Carlo-Stella
Summary: Loncastuximab tesirine shows substantial antitumor activity and acceptable safety profile in patients with relapsed or refractory DLBCL, potentially offering a new therapeutic option for heavily pretreated individuals.
Review
Oncology
Bo Xu, Shaoqian Li, Bo Kang, Shangzhi Fan, Zunbo He, Jiecan Zhou
Summary: The novel antibody-drug conjugate, camidanlumab tesirine, has shown promising efficacy in heavily pretreated patients with relapsed or refractory classic Hodgkin lymphoma, with high response rates and durable responses. However, adverse events such as fatigue, rash, and anemia are commonly observed.
INVESTIGATIONAL NEW DRUGS
(2022)
Article
Oncology
Marie Toukam, Jens Wuerthner, Karin Havenith, Mehdi Hamadani, Paolo F. Caimi, Tim Kopotsha, Hans G. Cruz, Joseph P. Boni
Summary: The purpose of this study was to develop a population pharmacokinetic (PPK) model to characterize the pharmacokinetics of camidanlumab tesirine (Cami) in patients with relapsed/refractory lymphoma. The final model obtained estimates of pharmacokinetic parameters and identified covariates that significantly affect Cami exposure.
CANCER CHEMOTHERAPY AND PHARMACOLOGY
(2023)
Article
Oncology
Marie Toukam, Joseph P. Boni, Mehdi Hamadani, Paolo F. Caimi, Hans G. Cruz, Jens Wuerthner
Summary: This study investigated the exposure-response relationships of Camidanlumab Tesirine (Cami) using an integrated population pharmacokinetic model. The results showed a significant positive relationship between exposure and overall response rate/overall survival, but this effect was non-significant in the final models due to covariate effects. Higher exposures of Cami were associated with a higher probability of experiencing grade >= 2 adverse events at cycle 6.
CANCER CHEMOTHERAPY AND PHARMACOLOGY
(2023)
Article
Oncology
Matthias Fischer, Lucas Moreno, David S. Ziegler, Lynley Marshall, C. Michel Zwaan, Meredith S. Irwin, Michela Casanova, Constantino Sabado, Beate Wulff, Mario Stegert, Luojun Wang, Felipe K. Hurtado, Fabrice Branle, Birgit Geoerger, Johannes H. Schulte
Summary: This study investigated the safety, pharmacokinetics, and efficacy of ceritinib in paediatric patients with ALK-positive malignancies. Results showed that the recommended dose for paediatric patients with ALK-positive malignancies is 500 mg/m(2) of ceritinib, which demonstrated promising antitumor activity.
Article
Medicine, General & Internal
Martin Hutchings, Rogier Mous, Michael Roost Clausen, Peter Johnson, Kim M. Linton, Martine E. D. Chamuleau, David John Lewis, Anna Sureda Balari, David Cunningham, Roberto S. Oliveri, Brian Elliott, Dena DeMarco, Ada Azaryan, Christopher Chiu, Tommy Li, Kuo-mei Chen, Tahamtan Ahmadi, Pieternella J. Lugtenburg
Summary: This study aimed to evaluate the safety and recommended dose of a novel bispecific antibody epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The results showed that the full dose of 48 mg was identified as the recommended phase 2 dose, and no maximum tolerated dose was reached during the treatment. Epcoritamab demonstrated good antitumor activity in some patients during the study.
Article
Hematology
Paolo Strati, Morton Coleman, Rebecca Champion, Shuo Ma, Caterina Patti, Moshe Y. Levy, Izidore S. Lossos, Praveen Ramakrishnan Geethakumari, Selay Lam, Roser Calvo, Kara Higgins, Lihua E. Budde
Summary: Acalabrutinib showed greater selectivity and improved safety compared to ibrutinib in patients with relapsed/refractory chronic lymphocytic leukaemia. In patients with relapsed/refractory marginal zone lymphoma, acalabrutinib demonstrated significant efficacy and tolerability.
BRITISH JOURNAL OF HAEMATOLOGY
(2022)
Article
Hematology
Mehdi Hamadani, John Radford, Carmelo Carlo-Stella, Paolo F. Caimi, Erin Reid, Owen A. O'Connor, Jay M. Feingold, Kirit M. Ardeshna, William Townsend, Melhem Solh, Leonard T. Heffner, David Ungar, Luqiang Wang, Joseph Boni, Karin Havenith, Yajuan Qin, Brad S. Kahl
Summary: Loncastuximab tesirine, an antibody-drug conjugate, shows promising efficacy and safety in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, especially for certain specific lymphoma subtypes. This study suggests that loncastuximab tesirine could be a valuable treatment option for these patients and warrants further investigation in phase 2 trials.
Review
Oncology
Narendranath Epperla, Mehdi Hamadani
Summary: Camidanlumab Tesirine (Cami) has shown activity in multiply relapsed/refractory classical Hodgkin lymphoma (cHL) patients. Treatment with Cami was associated with adverse events, but overall clinical efficacy is encouraging.
CURRENT HEMATOLOGIC MALIGNANCY REPORTS
(2021)
Article
Biotechnology & Applied Microbiology
Krishna Goparaju, Paolo F. Caimi
Summary: Loncastuximab tesirine is an antiCD19 antibody drug conjugate with a unique cytotoxic payload. Early studies have shown the drug to be tolerable, with a safety profile different from other approved antibody drug conjugates for lymphoid malignancies. Efficacy data indicates activity in various non-Hodgkin lymphoma types, with a phase 2 study in DLBCL demonstrating durable responses, even in high-risk subgroups. Loncastuximab tesirine is expected to be a significant addition to DLBCL treatment options.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2021)
Article
Medicine, General & Internal
Bijal D. Shah, Armin Ghobadi, Olalekan O. Oluwole, Aaron C. Logan, Nicolas Boissel, Ryan D. Cassaday, Thibaut Leguay, Michael R. Bishop, Max S. Topp, Dimitrios Tzachanis, Kristen M. O'Dwyer, Martha L. Arellano, Yi Lin, Maria R. Baer, Gary J. Schiller, Jae H. Park, Marion Subklewe, Mehrdad Abedi, Monique C. Minnema, William G. Wierda, Daniel J. DeAngelo, Patrick Stiff, Deepa Jeyakumar, Chaoling Feng, Jinghui Dong, Tong Shen, Francesca Milletti, John M. Rossi, Remus Vezan, Behzad Kharabi Masouleh, Roch Houot
Summary: KTE-X19 demonstrated a high rate of complete remission or complete remission with incomplete haematological recovery in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia. Median overall survival was not reached in responding patients, and the therapy showed a manageable safety profile. These findings suggest that KTE-X19 has the potential to provide long-term clinical benefit to these patients.
Review
Pharmacology & Pharmacy
Bo Xu
Summary: Loncastuximab tesirine is a CD19-targeted ADC that meets the unmet needs of heavily pretreated R/R DLBCL patients, showing good safety and efficacy in clinical trials.
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Article
Hematology
Jesus San-Miguel, Saad Z. Usmani, Maria-Victoria Mateos, Niels W. C. J. van de Donk, Jonathan L. Kaufman, Philippe Moreau, Albert Oriol, Torben Plesner, Lotfi Benboubker, Kevin Liu, Peter Hellemans, Tara Masterson, Pamela L. Clemens, Man Luo, Andrew Farnsworth, Hareth Nahi, Ajai Chari
Summary: The subcutaneous formulation of daratumumab with rHuPH20 in the PAVO study showed good tolerability and efficacy similar to intravenous daratumumab. The concentrated pre-mixed co-formulation (DARA SC) achieved comparable daratumumab trough concentrations as intravenous dosing, with a lower infusion-related reaction rate. Ongoing studies are further investigating the use of DARA SC in the treatment of multiple myeloma and other conditions.
Article
Oncology
David M. Loeb, Ji Won Lee, Daniel A. Morgenstern, Yvan Samson, Anne Uyttebroeck, Chuhl Joo Lyu, An Van Damme, Karsten Nysom, Margaret E. Macy, Alexandra P. Zorzi, Julia Xiong, Petra Pollert, Ingrid Joerg, Yulia Vugmeyster, Mary Ruisi, Hyoung Jin Kang
Summary: In paediatric patients with refractory/relapsed solid tumours, avelumab monotherapy showed a safety profile consistent with previous adult studies, but clinical benefits were limited.
CANCER IMMUNOLOGY IMMUNOTHERAPY
(2022)
