On Location ASH Annual Meeting
Continued from page 47
stable disease (SD; n=25); at the first tumor assessment (1
month post-infusion), 23 patients with either PR or SD
subsequently achieved CR up to 15 months, without ad-
ditional therapy. The median time to conversion from PR
to CR was 64 days (range = 49-424 days).
Median duration of CR had not been reached by data
cutoff, with three of seven patients (43%) in ongoing CR
at 24 months. Median progression-free survival was 5.8
months (range = 3.3 months – not reached), while the
median overall survival (OS) was not reached (range =
12.0 months – not reached).
“Patients who are in remission at six months tend to
stay in remission,” Dr. Neelapu said, adding that, while the
median OS was not reached, “there is a plateauing of the OS
curve at the 16-month timepoint.”
The investigators also reviewed baseline and post-
progression biopsies for 12 evaluable patients, shedding
some light on why certain patients’ disease fails to respond
to treatment. About one-third of patients experienced
CD19 antigen loss at the time of disease progression, and 80
percent of patients evaluable for PD-L1 at the time of disease
progression had PD-L1–positive disease (see TABLE 3 ). “Loss
of CD19 and gain of PD-L1 expression in tumors are
identified as possible mechanisms of resistance following
axicabtagene ciloleucel treatment,” the authors noted.
The safety profile was consistent with previously reported
studies of axicabtagene ciloleucel, Dr. Neelapu added. In earlier
analysis of ZUMA-1, four patients died within two months
after CAR T-cell infusion, two of which were deemed related
to study treatment and two attributable to unrelated adverse
events (AEs). In this longer-term follow-up, no new treatment-
related deaths were observed.
Nearly all patients experienced at least one grade ≥3
T:7”
POMALYST ® (pomalidomide) capsules, for oral use 2.2 Dose Adjustments for Toxicities
The following is a Brief Summary; refer to full
Prescribing Information for complete product
information. Table 1: Dose Modification Instructions for
POMALYST for Hematologic Toxicities
WARNING: EMBRYO-FETAL TOXICITY and
VENOUS AND ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
• POMALYST is contraindicated in pregnancy.
POMALYST is a thalidomide analogue.
Thalidomide is a known human teratogen that
causes severe birth defects or embryo-fetal
death. In females of reproductive potential,
obtain 2 negative pregnancy tests before
starting POMALYST treatment.
• Females of reproductive potential must use 2
forms of contraception or continuously abstain
from heterosexual sex during and for 4 weeks
after stopping POMALYST treatment [see
Contraindications (4), Warnings and Precautions
(5.1), and Use in Specific Populations (8.1, 8.3)].
POMALYST is only available through a restricted
distribution program called POMALYST REMS
[see Warnings and Precautions (5.2)].
Venous and Arterial Thromboembolism
• Deep venous thrombosis (DVT), pulmonary
embolism (PE), myocardial infarction, and
stroke occur in patients with multiple myeloma
treated with POMALYST. Prophylactic
antithrombotic measures were employed in
clinical trials. Thromboprophylaxis is
recommended, and the choice of regimen
should be based on assessment of the
patient’s underlying risk factors [see Warnings
and Precautions (5.3)].
2 DOSAGE AND ADMINISTRATION
2.1 Multiple Myeloma
Females of reproductive potential must have negative
pregnancy testing and use contraception methods
before initiating POMALYST [see Warnings and
Precautions (5.1) and Use in Specific Populations
(8.3)].
The recommended starting dose of POMALYST is
4 mg once daily orally on Days 1-21 of repeated
28-day cycles until disease progression.
POMALYST should be given in combination with
dexamethasone.
POMALYST may be taken with water. Inform patients
not to break, chew, or open the capsules. POMALYST
may be taken with or without food.
Dose Modification
• Interrupt POMALYST
treatment, follow CBC
weekly
• Resume POMALYST
treatment at 3 mg daily
• For each subsequent • Interrupt POMALYST
drop <500 per mcL
treatment
• Return to more than or • Resume POMALYST
equal to 500 per mcL
treatment at 1 mg less
than the previous dose
Thrombocytopenia
• Platelets <25,000 per
mcL
• Platelets return to
>50,000 per mcL
• Interrupt POMALYST
treatment, follow CBC
weekly
• Resume POMALYST
treatment at 3 mg daily
• For each subsequent • Interrupt POMALYST
drop <25,000 per mcL treatment
• Resume POMALYST
• Return to more than
or equal to 50,000 per treatment at 1 mg less
than previous dose
mcL
ANC, absolute neutrophil count
To initiate a new cycle of POMALYST, the neutrophil
count must be at least 500 per mcL and the platelet
count must be at least 50,000 per mcL. If toxicities
occur after dose reductions to 1 mg, then
discontinue POMALYST.
Permanently discontinue POMALYST for