Faculty Bibliography

Pancreatic ductal adenocarcinoma (PDAC) remains a highly lethal malignancy and has long been regarded as a therapeutic "drug graveyard", with modest gains from cytotoxic combination chemotherapy and numerous novel agents failing to show benefit in clinical trials. The quest to directly target RAS has moved from concept to reality with the FDA approval of daraxonrasib (Rasonque) for adults with metastatic PDAC who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Here we discuss a wave of clinical trials that are poised to change this narrative and usher in the era of RAS-targeted therapy. Given the flood of compounds and combinations, we focus on therapies that have advanced to phase 3 clinical trials. Collectively, these studies demonstrate how RAS-targeted therapies are poised to transform the PDAC treatment landscape. The current generation of trials will determine whether these emerging strategies can translate into durable survival gains and turn PDAC from a "drug graveyard" into a drug haven for novel therapies.

Contact dermatitis (CD) is the 5th most common skin disease1 and affects 15-20% of the general population over their lifetimes.2 Currently, the T.R.U.E. TEST® is the only FDA-approved diagnostic product to aid in the diagnosis of Allergic Contact Dermatitis. To address that diagnostic gap, the US Food and Drug Administration held a public workshop in October 2025. These proceedings summarize the workshop presentations and discussions.

Myocardial strain imaging enables quantification of cardiac deformation. Cardiovascular magnetic resonance imaging (CMR) is well suited for strain assessment due to the ability to image in any given plane with high spatial and contrast resolution. CMR strain measures have incremental diagnostic and prognostic utility over conventional clinical imaging parameters across disease states. Routine integration of CMR strain assessment in clinical practice has been hindered by the lack of agreement on imaging protocols and analysis methods, variability due to noise sensitivity, and a paucity of robust normative age-, sex- and ethnicity-specific reference ranges. In recognition of the expanding applications of strain techniques in clinical and research CMR, this joint SCMR/RSNA/EACVI scientific statement integrates data from original research studies, guidelines, and opinions from experts across the field to guide responsible and evidence-based utilization of CMR strain.

BACKGROUND:Bispecific T-cell-engaging antibodies against BCMA and GPRC5D demonstrate high efficacy in relapsed/refractory multiple myeloma (RRMM) but are associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), traditionally prompting inpatient monitoring when commencing therapy. Contemporary step-up dosing and prophylactic strategies may enable safe outpatient administration. PATIENTS AND METHODS/METHODS:We conducted a single-center retrospective study evaluating outpatient step-up dosing (SUD) of teclistamab or talquetamab in adults with RRMM. Patients met institutional outpatient eligibility criteria and received standard pre-medications; prophylactic tocilizumab was administered at physician discretion. The primary endpoint was incidence and severity of CRS/ICANS. Secondary endpoints included SUD completion, healthcare utilization, and need for hospitalization. RESULTS:Thirty-eight patients underwent 43 outpatient SUD initiations (teclistamab n = 30; talquetamab n = 13). Median age was 72 years, and disease burden was high. SUD completion occurred in 93%. CRS occurred in 26% of initiations and was exclusively grade 1-2; no grade ≥ 3 CRS occurred. One possible grade III ICANS event (2%) occurred after completion of SUD. CRS incidence was similar with and without prophylactic tocilizumab (29% vs 32%). Most events occurred during the first two step-up doses. Hospitalization occurred in 5 (12%) SUD initiations for CRS/ICANS events and overall healthcare utilization was modest. CONCLUSION/CONCLUSIONS:Outpatient administration of teclistamab and talquetamab SUD in RRMM is feasible and safe with low rates of low-grade CRS. Toxicities occur early and are manageable with structured monitoring, supporting outpatient delivery in appropriately selected patients.

BACKGROUND:Bispecific T-cell-engaging antibodies against BCMA and GPRC5D demonstrate high efficacy in relapsed/refractory multiple myeloma (RRMM) but are associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), traditionally prompting inpatient monitoring when commencing therapy. Contemporary step-up dosing and prophylactic strategies may enable safe outpatient administration. PATIENTS AND METHODS/METHODS:We conducted a single-center retrospective study evaluating outpatient step-up dosing (SUD) of teclistamab or talquetamab in adults with RRMM. Patients met institutional outpatient eligibility criteria and received standard pre-medications; prophylactic tocilizumab was administered at physician discretion. The primary endpoint was incidence and severity of CRS/ICANS. Secondary endpoints included SUD completion, healthcare utilization, and need for hospitalization. RESULTS:Thirty-eight patients underwent 43 outpatient SUD initiations (teclistamab n = 30; talquetamab n = 13). Median age was 72 years, and disease burden was high. SUD completion occurred in 93%. CRS occurred in 26% of initiations and was exclusively grade 1-2; no grade ≥ 3 CRS occurred. One possible grade III ICANS event (2%) occurred after completion of SUD. CRS incidence was similar with and without prophylactic tocilizumab (29% vs 32%). Most events occurred during the first two step-up doses. Hospitalization occurred in 5 (12%) SUD initiations for CRS/ICANS events and overall healthcare utilization was modest. CONCLUSION/CONCLUSIONS:Outpatient administration of teclistamab and talquetamab SUD in RRMM is feasible and safe with low rates of low-grade CRS. Toxicities occur early and are manageable with structured monitoring, supporting outpatient delivery in appropriately selected patients.

Pancreatic ductal adenocarcinoma (PDAC) remains a highly lethal malignancy and has long been regarded as a therapeutic "drug graveyard", with modest gains from cytotoxic combination chemotherapy and numerous novel agents failing to show benefit in clinical trials. The quest to directly target RAS has moved from concept to reality with the FDA approval of daraxonrasib (Rasonque) for adults with metastatic PDAC who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Here we discuss a wave of clinical trials that are poised to change this narrative and usher in the era of RAS-targeted therapy. Given the flood of compounds and combinations, we focus on therapies that have advanced to phase 3 clinical trials. Collectively, these studies demonstrate how RAS-targeted therapies are poised to transform the PDAC treatment landscape. The current generation of trials will determine whether these emerging strategies can translate into durable survival gains and turn PDAC from a "drug graveyard" into a drug haven for novel therapies.

IMPORTANCE/UNASSIGNED:The Centers for Medicare & Medicaid Services requires that health systems offer smoking cessation services to patients undergoing lung cancer screening. However, the most effective methods to achieve smoking cessation among medically underserved patients undergoing lung cancer screening are unknown. OBJECTIVE/UNASSIGNED:To compare the effectiveness of 4 strategies for promoting smoking cessation among medically underserved persons referred for lung cancer screening. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This randomized clinical trial included currently smoking individuals referred for lung cancer screening at 4 US health systems (5 centers) who identified as Black, Hispanic, living in a rural area, or being of low socioeconomic status. The first participant was enrolled on May 17, 2021, and the date of last follow-up was April 29, 2025. INTERVENTION/UNASSIGNED:Patients were randomized to 1 of 4 groups. Participants received either an ask-advise-refer strategy to smoking cessation services (usual care); usual care plus free pharmacotherapy (ie, nicotine replacement and reimbursement for varenicline or bupropion); usual care, free pharmacotherapy, and financial incentives up to $600 contingent on biochemically confirmed smoking cessation; or usual care, free pharmacotherapy, and financial incentives plus a mobile health tool motivating patients to think about their future health. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary end point was biochemically confirmed, sustained tobacco abstinence through 6 months, measured with cotinine, anabasine, or carboxyhemoglobin. RESULTS/UNASSIGNED:Of the 9963 patients assessed for eligibility, 3259 patients were randomized and 3220 were included in the primary analysis. The median (IQR) age was 61.1 (56.6-66.0) years, 1948 (60.3%) were female, 823 (25.5%) were Black, 287 (8.9%) were Hispanic, 1251 (38.8%) lived in rural areas, 1519 (74.9%) had low socioeconomic status, and 1792 (55.5%) reported smoking more than 10 cigarettes per day at enrollment. Sustained tobacco abstinence rates through 6 months were 4.3% with usual care, 5.1% with the addition of pharmacotherapy, 8.8% with the addition of financial incentives, and 7.2% with the addition of mobile health tool. Adding financial incentives increased the adjusted rate of sustained tobacco abstinence compared with usual care (difference, 4.6% [95% CI, 2.1%-7.0%]; P < .001) and usual care plus free pharmacotherapy (difference, 4.1% [95% CI, 1.7%-6.4%]; P < .001). Adding free pharmacotherapy to ask-advise-refer was not superior to ask-advise-refer alone (difference, 0.5% [95% CI, -1.7% to 2.6%]; P = .66). CONCLUSIONS AND RELEVANCE/UNASSIGNED:Among medically underserved adults who currently smoked cigarettes and were referred for lung cancer screening, rates of sustained tobacco abstinence were higher through 6 months with addition of financial incentives compared with ask-advise-refer alone or with addition of free pharmacotherapy. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04798664.

Myocardial strain imaging enables quantification of cardiac deformation. Cardiovascular magnetic resonance imaging (CMR) is well suited for strain assessment due to the ability to image in any given plane with high spatial and contrast resolution. CMR strain measures have incremental diagnostic and prognostic utility over conventional clinical imaging parameters across disease states. Routine integration of CMR strain assessment in clinical practice has been hindered by the lack of agreement on imaging protocols and analysis methods, variability due to noise sensitivity, and a paucity of robust normative age-, sex- and ethnicity-specific reference ranges. In recognition of the expanding applications of strain techniques in clinical and research CMR, this joint SCMR/RSNA/EACVI scientific statement integrates data from original research studies, guidelines, and opinions from experts across the field to guide responsible and evidence-based utilization of CMR strain.

Contact dermatitis (CD) is the 5th most common skin disease1 and affects 15-20% of the general population over their lifetimes.2 Currently, the T.R.U.E. TEST® is the only FDA-approved diagnostic product to aid in the diagnosis of Allergic Contact Dermatitis. To address that diagnostic gap, the US Food and Drug Administration held a public workshop in October 2025. These proceedings summarize the workshop presentations and discussions.