ASH Annual Meeting Preview
Dr . Kile : The session on iron therapeutics runs the gamut from fundamental molecular science to therapy , and I am looking forward to the fantastic session on AI from the Scientific Committee on Hematopathology and clinical Laboratory Hematology . There is a lot of talk about AI ’ s potential to revolutionize clinical practice , so this session is going to cover the real impact being felt now – rather than discussing AI as some sort of magical solution .
The Scientific Committee on Myeloid Biology ’ s session on cell memory and innate immune pathways is going to be absolutely fantastic . We always thought the innate immune pathways were the “ dumb ” part of the immune system – basic and non-adaptive . Well , of course , it ’ s way more complicated than that . The element of memory has profound implications for response to pathogens and in malignancies , such as the way the immune system is persuaded to ignore tumors or how memory underpins the immune response to cancer .
Cell Memory and Innate Immune Pathways During Myeloid Cell Development Function
Sunday , December 12 , 2021 , 9:30 a . m . - 10 : 15 a . m . Georgia World Congress Center , C108-C109 , Level 1
Are New Clinical Trial Designs Effective ?
Among the goals of the ASH Subcommittee on Clinical Trials is to increase accrual to clinical trials within the hematology space , ensure diversity among participants of these trials , and make sure that new drugs obtain approval in the safest and most efficient ways possible . Expedited review programs and adaptive trial designs have led to record numbers of drug
DARZALEX FASPRO ®
( daratumumab and hyaluronidase-fihj ): subcutaneous administration in ~ 3 to 5 minutes 1
SAME POWERFUL EFFICACY . FASTER ADMINISTRATION . 1 , 2 *
Approved across 7 indications spanning a wide range of multiple myeloma patients 1 approvals in recent years , but questions remain about the safety and efficacy of these agents .
As part of this year ’ s program , a panel of experts will address the recent surge in hematology drug approvals , and how clinicians should interpret the data behind these approvals , in an Education Spotlight Session called “ Approved , But Should
ASH-EHA Joint Symposium : Targeting Macrophages and the Innate Immune System to Treat Hematologic Malignancies
Sunday , December 12 , 2021 , 12:30 p . m . - 1:30 p . m . Georgia World Congress Center , Hall C2-C3
Which sessions are you adding to your own agendas ? Dr . Abdel-Wahab : Sessions that I know are going to be well attended are those on immunotherapy in hematology , covering chimeric antigen receptor T-cell therapy and natural killer cells .
Dr . Kile : I am looking forward to the ASH-EHA Joint Symposium , featuring Ravi Majeti , MD , PhD , and Claudia Lengerke , MD . Again , this joint session speaks to this year ’ s collaborative spirit and focus on the immune system . Drs . Majeti and Lengerke will discuss manipulation of the innate immune system for therapeutic gain in malignancies .
28 ASH Clinical News
INDICATIONS
DARZALEX FASPRO ® ( daratumumab and hyaluronidase-fihj ) is indicated for the treatment of adult patients with multiple myeloma :
• In combination with bortezomib , melphalan , and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
• In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
• In combination with bortezomib , thalidomide , and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
• In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
• In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
• As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor ( PI ) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
DARZALEX FASPRO ® is contraindicated in patients with a history of severe hypersensitivity to daratumumab , hyaluronidase , or any of the components of the formulation .
WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
Both systemic administration-related reactions , including severe or life-threatening reactions , and local injection-site reactions can occur with DARZALEX FASPRO ® . Fatal reactions have been reported with daratumumab-containing products , including DARZALEX FASPRO ® .
Systemic Reactions In a pooled safety population of 832 patients with multiple myeloma ( N = 639 ) or light chain ( AL ) amyloidosis ( N = 193 ) who received DARZALEX FASPRO ® as monotherapy or in combination , 9 % of patients experienced a systemic administration-related reaction ( Grade 2 : 3.5 %, Grade 3 : 0.8 %). Systemic administration-related reactions occurred in 8 % of patients with the first injection , 0.4 % with the second injection , and cumulatively 1 % with subsequent injections . The median time to onset was 3.2 hours ( range : 9 minutes to 3.5 days ). Of the 129 systemic administration-related reactions that occurred in 74 patients , 110 ( 85 %) occurred on the day of DARZALEX FASPRO ® administration . Delayed systemic administration-related reactions have occurred in 1 % of the patients . Severe reactions included hypoxia , dyspnea , hypertension , and tachycardia . Other signs and symptoms of systemic administrationrelated reactions may include respiratory symptoms , such as bronchospasm , nasal congestion , cough , throat irritation , allergic rhinitis , and wheezing , as well as anaphylactic reaction , pyrexia , chest pain , pruritus , chills , vomiting , nausea , and hypotension . Pre-medicate patients with histamine-1 receptor antagonist , acetaminophen , and corticosteroids . Monitor patients for systemic administration-related reactions , especially following the first and second injections . For anaphylactic reaction or life-threatening ( Grade 4 ) administration-related reactions , immediately and permanently discontinue DARZALEX FASPRO ® . Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO ® depending on dosing regimen and medical history to minimize the risk of delayed ( defined as occurring the day after administration ) systemic administration-related reactions .
Local Reactions In this pooled safety population , injection-site reactions occurred in 8 % of patients , including Grade 2 reactions in 0.6 %. The most frequent (> 1 %) injection-site reaction was injection-site erythema . These local reactions occurred a median of 5.5 minutes ( range : 0 minutes to 6.5 days ) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management .