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Better treatment options for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) are needed. Epcoritamab is a subcutaneous CD3xCD20 bispecific antibody with preliminary potent antitumor activity. We report primary results from the LBCL expansion cohort for epcoritamab in patients with R/R B-cell NHL (EPCORE NHL-1; NCT03625037). Adults with R/R CD20+ LBCL were included. Patients had DLBCL (including double/triple-hit and transformed), HGBCL, PMBCL, or FL grade (G) 3B. As of January 31, 2022, 157 patients were treated. Patients received epcoritamab (priming and intermediate doses followed by 48 mg) as 1-mL subcutaneous injections [QW, cycle (C) 1-3; Q2W, C4-9; Q4W, C ≥10] until disease progression or unacceptable toxicity. Patients had a median of 3 (range, 2-11) prior lines of therapy (LOT), 61 (38.9%) received prior CAR T, 61% had primary refractory disease, and 83% were refractory to the last LOT. With a median follow-up of 10.7 mo, ORR by IRC (Lugano/PET-CT) was 63% with 39% complete response (CR). ORR/CR rates were 69%/42% for CAR T-naive patients and 54%/34% for CAR T-exposed patients. Median duration of response was 12 mo and not reached among complete responders. ORR was similar across prespecified subgroups of age, prior LOT, and de novo or transformed disease. The most common treatment-emergent AEs were CRS (49.7%; 31.8% G1, 15.3% G2, 2.5% G3), pyrexia (23.6%), fatigue (22.9%), neutropenia (21.7%), and diarrhea (20.4%). Ten patients (6.4%) experienced ICANS; all but one event was G1-2, and the G5 ICANS was the only treatment-related death. Epcoritamab is a convenient, subcutaneous therapy that demonstrated clinically meaningful, compelling efficacy including deep and durable responses in a challenging-to-treat, highly refractory LBCL population. Efficacy was observed in both CAR T-exposed and CAR T-naive patients. The safety profile was manageable and consistent with previous findings. Funding: This study was funded by Genmab A/S and AbbVie. Encore statement: This abstract was accepted to the European Hematology Association Annual Congress; June 9-17, 2022; Vienna, Austria, and virtual. [ABSTRACT FROM AUTHOR]

Rising health care costs are threatening the fiscal solvency of patients, employers, payers, and governments. The Collaborative Payer Provider Model (CPPM) addresses this challenge by reinventing the role of the payer into a full-service collaborative ally of the physician. From 2010 through 2014, a Medicare Advantage plan prospectively deployed the CPPM, averaging 30,561 members with costs that were 73.6% of fee-for-service (FFS) Medicare (p < 0.001). The health plan was not part of an integrated delivery system. After allocating $80 per member per month (PMPM) for primary care costs, the health plan had medical cost ratios averaging 75.1% before surplus distribution. Member benefits were the best in the market. The health plan was rated 4.5 Stars by the Centers for Medicare and Medicaid Services for years 1-4, and 5 Stars in study year 5 for quality, patient experience, access to care, and care process metrics. Primary care and specialist satisfaction were significantly better than national benchmarks. Savings resulted from shifts in spending from inpatient to outpatient settings, and from specialists to primary care physicians when appropriate. The CPPM is a scalable model that enables a win-win-win system for patients, providers, and payers. [ABSTRACT FROM AUTHOR]

Background: The immunomodulatory agent pomalidomide in combination with low-dose dexamethasone has demonstrated efficacy and safety for the treatment of relapsed and refractory multiple myeloma (RRMM) in phase 2 and 3 trials. However, these trials enrolled very few Asian patients. Methods: This phase 2 study investigated pomalidomide plus low-dose dexamethasone in 36 Japanese patients with RRMM after ≥2 prior therapies. Results: Patients enrolled in the study had a relatively high disease burden (81% Durie-Salmon stage II or III) and were heavily pretreated (median, 6.5 prior antimyeloma regimens). The overall response rate was 42% (1 patient with complete response and 14 with partial response), with an additional 44% (16 patients) achieving stable disease (SD). Response rates in patients aged ≤65 years and >65 years were 47 and 35%, respectively. None of the five patients with extramedullary disease achieved a response, with three of them maintaining SD of short duration. Median progression-free survival was 10.1 months after a 7.7-month median follow-up, and the median overall survival was not reached. The most frequent grade ≥3 adverse events (AEs) were neutropenia (64%), anemia (42%), and thrombocytopenia (31%). The most frequent nonhematologic grade ≥3 AEs were pneumonia and decreased appetite (8% each). Adverse events in patients aged >65 years were similar to those in patients aged ≤65 years, except for a higher rate of grade ≥3 pneumonia. Conclusions: Collectively, the results of this study demonstrate that pomalidomide plus low-dose dexamethasone is an effective and safe treatment for Japanese patients with RRMM, although careful attention needs to be paid to serious infections. [ABSTRACT FROM AUTHOR]

This phase 1, open-label, dose-escalation study investigated the tolerated dose (recommended dose), safety, efficacy, and pharmacokinetics of pomalidomide alone or pomalidomide plus low-dose dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. Twelve patients were enrolled. Patients received pomalidomide 2 mg (Cohort 1) or 4 mg (Cohort 2) orally on day 1 and days 3-21 of a 28-day cycle. The tolerated dose of pomalidomide was determined to be 4 mg given on days 1-21 of a 28-day cycle. Efficacy outcomes with pomalidomide plus low-dose dexamethasone were consistent with those of previous studies. Responses (partial response or better) were achieved by three patients (25%; 1 [17%] in Cohort 1 and 2 [33%] in Cohort 2), and the median time to response was 6.4 months overall (9.0 months for Cohort 1 and 4.2 months for Cohort 2). The median progression-free survival was 5.5 months overall (5.1 months for Cohort 1 and not reached for Cohort 2). The most frequently occurring grade ≥3 adverse events were neutropenia (67%), anemia (25%), lymphopenia (25%), and pneumonia (25%), consistent with previous studies of pomalidomide plus low-dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Further investigation of pomalidomide is recommended for Japanese patients with refractory or relapsed and refractory multiple myeloma. This study was registered with ClinicalTrials.gov (NCT01568294). [ABSTRACT FROM AUTHOR]

Purpose: Although newer, heavily promoted medications are commonly prescribed, published evidence and consensus guidelines often support the use of less expensive alternatives. This study was designed to evaluate the impact on prescription costs of a computerized decision support system (CDSS) that provides evidence-based recommendations to clinicians during the electronic prescribing process.Methods: A retrospective cohort study was performed using a pharmacy claims database. Clinicians using the CDSS were matched with a control group by pharmacy billed amount, number of patients treated, and number of new prescriptions filled during a 6-month baseline period in which neither group used the system. The primary outcome measure was the difference in prescription costs between the 2 groups after implementation of the CDSS in the intervention group.Results: Clinicians who received evidence-based messages had significantly lower prescription costs than those in the control group. The average cost per new prescription was 4.16 dollars lower (P = .02) in the intervention group, and the average cost for new and refilled prescriptions was 4.99 dollars lower (P = .01). The 6-month savings from new prescriptions and their refills are estimated to be 3,450 dollars (95% CI, 1,030-5,863 dollars) per clinician.Conclusions: Providing electronic, evidence-based decision support during the prescribing process can shift prescribing decisions toward more evidence-based care and significantly decrease primary care prescription costs. [ABSTRACT FROM AUTHOR]

Presents letters to the editor. Role of immune function in human papillomavirus infection (HPV); Response to an article regarding approaches to discussing cancer screening with elderly patients; Mention of a study of sexual solicitation of youth on the Internet; Others.

In DDD-pacemaker patients with high degree AV block, Doppler echocardiography of transmittal blood flow can be used to find the individually optimal AV delay (AVO) for left heart AV synchronization. This study tried to validate a Doppler method (ECHO) recently proposed to optimize left ventricular filling by comparing it to stroke volume data derived from impedance cardiography (ICG). It should be further elucidated if optimizing the AV delay (,4 VD) by means of this method is superior to fixed AVD settings and which differential AVD (pace-sense-offset) should be programmed for atrially triggered (A TP) and AV sequential (AVP) pacing, respectively. AVO as measured in 53 patients showed a linear correlation between ECHO and ICG for both ATP (r = 0.66, P< 0.00001) and AVP (r = 0.53, P < 0.005). The mean deviation in AVO between ECHO and ICG was ± 26 ms (ATP) and ± 30 ms (AVP), respectively, with a tendency to longer AVDs with the Doppler method. ECHO limitations could mainly be attributed to: (1) restrictions of AVD programming options (which may be compensated for by slight modification of the proposal); and (2) to pathophysiological mechanisms that alter mitral valve dynamics. Optimization of the AVD by Doppler produced a stroke volume that was significantly higher (19%) than with a fixed AVD (150 ms in ATP; 200 ms in AVP). There was a wide scatter in pace-sense-offsets between -7 and 134 ms, which was reflected by both methods. It is concluded that AVO determinations by ECHO are valid provided that methodological pitfalls and limitations caused by the disease are recognized. Tailoring AVD with respect to diastolic filling improves systolic function and is superior to nominal AVD settings. Fixed differential AVDs as offered by some manufacturers are far from being physiological. Thus modern pulse generators should offer free programmability over a wide range of AV delays. [ABSTRACT FROM AUTHOR]