ACN_7.14_Full Issue digital | Page 33

SPOTLIGHT agents based on results from single-arm studies could lead to the approval of a lot of new agents . What has also become more common , and we will give examples during the session , is the concept of using a “ synthetic control ” arm . With this design , researchers collect data on patients being treated in practice – so-called real-world data – to match the characteristics of patients being treated in the context of a clinical trial . This approach was used with the approval of tafasitamab plus lenalidomide for DLBCL . Investigators could not have developed a good conventional control arm because of the effects of lenalidomide alone in that population . This is a new trend and practicing physicians need to understand how to interpret these data and what the limitations are .

What do you think attendees will learn from this session ? I hope people come away from this session with continued enthusiasm over the current era of riches in terms of new drug development . I want people to have a better understanding about how the FDA views these types of “ synthetic control ” trials and how the agency expects clinicians to use these approved drugs – appreciating that the decision was based on far fewer data than what would have been collected with a full approval from a phase III trial .

DARZALEX FASPRO ^® ( daratumumab and hyaluronidase-fihj ) injection

DARZALEX FASPRO ^® ( daratumumab and hyaluronidase-fihj ) injection

Table 2 : Select Hematology Laboratory Abnormalities Worsening from Baseline in Patients Who Received DARZALEX FASPRO with Bortezomib , Melphalan and Prednisone ( DARZALEX FASPRO-VMP ) in PLEIADES

DARZALEX FASPRO with Bortezomib , Melphalan and Prednisone ^a

Laboratory Abnormality

All Grades (%) Grades 3-4 (%) Decreased leukocytes 96 52 Decreased lymphocytes 93 84 Decreased platelets 93 42 Decreased neutrophils 88 49 Decreased hemoglobin 48 19 a Denominator is based on the safety population treated with DARZALEX FASPRO-VMP ( N = 67 ).

Relapsed / Refractory Multiple Myeloma

In Combination with Lenalidomide and Dexamethasone The safety of DARZALEX FASPRO with lenalidomide and dexamethasone was evaluated in a single-arm cohort of PLEIADES [ see Clinical Studies ( 14.2 ) in Full Prescribing Information ]. Patients received DARZALEX FASPRO 1,800 mg / 30,000 units administered subcutaneously once weekly from weeks 1 to 8 , once every 2 weeks from weeks 9 to 24 and once every 4 weeks starting with week 25 until disease progression or unacceptable toxicity ( N = 65 ) in combination with lenalidomide and dexamethasone . Among these patients , 92 % were exposed for 6 months or longer and 20 % were exposed for greater than one year .

Serious adverse reactions occurred in 48 % of patients who received DARZALEX FASPRO . Serious adverse reactions in > 5 % of patients included pneumonia , influenza and diarrhea . Fatal adverse reactions occurred in 3.1 % of patients .

Permanent discontinuation of DARZALEX FASPRO due to an adverse reaction occurred in 11 % of patients who received DARZALEX FASPRO . Adverse reactions resulting in permanent discontinuation of DARZALEX FASPRO in more than 1 patient were pneumonia and anemia .

Dosage interruptions due to an adverse reaction occurred in 63 % of patients who received DARZALEX FASPRO . Adverse reactions requiring dosage interruptions in > 5 % of patients included neutropenia , pneumonia , upper respiratory tract infection , influenza , dyspnea , and blood creatinine increased .

The most common adverse reactions ( ≥20 %) were fatigue , diarrhea , upper respiratory tract infection , muscle spasms , constipation , pyrexia , pneumonia , and dyspnea .

Table 3 summarizes the adverse reactions in patients who received DARZALEX FASPRO in PLEIADES .