Oncopharmpod

Two recent publications suggest modifications to standard subcutaneous daratumumab pre-meds is safe...and saves time! Padmaraju et al experience from Chicago Med Center: https://doi.org/10.1093/oncolo/oyae158 Vazirnia et al experience from Mayo Clinic: https://doi.org/10.1200/OP.23.00470 We end summarizing some emerging evidence about the need, or lack thereof, for pre-paclitaxel H2RAs.

We take a deep look at the recently published, and guideline changing, AMPLIFY trial of fixed-duration acalabrutinib in CLL. Link: DOI: 10.1056/NEJMoa2409804

Morbidity & Mortality (M & M) are common case conferences to learn from unfortunate cases to improve care in the future. This episode looks at two recently published case reports. 1. Fatal tumor lysis syndrome following a lack of venetoclax ramp-up in AML: https://www.jhoponline.com/issue-archive/2024-issues/december-2024-vol-14-no-6/rapid-onset-of-fatal-tumor-lysis-syndrome-in-a-patient-with-acute-myeloid-leukemia-receiving-azacitidine-and-venetoclax-without-a-ramp-up-schedule-a-case-report 2. CD4+ T-cell lymphoma harboring a CAR integration into TP53: https://www.nejm.org/doi/full/10.1056/NEJMoa2411507

Dipping into the archives (technology issues with new computer) to re-release the Foundations of OncoPharm episode on rituximab. Where did that 375 mg/m2 dose come from anyway?

FDA approves two new treatment regimens: 1. Acalabrutinib + BR for untreated mantle cell lymphoma patients deemed ineligible for autologous HSCT 2. Sotorasib + panitumumab for KRAS-G12C mutated metastatic colorectal cancer (after chemotherapy, including oxaliplatin and irinotecan)

Datopotamab deruxtecan, a newly approved agent for breast cancer, is discussed.

HOPA Pharmacy Outcomes & Practice-Based Collaboration Survey: https://www.surveymonkey.com/r/MXNVRBR Dexamethasone Dosing Intensity in Multiple Myeloma: https://doi.org/10.1182/blood.2024025939 Talquetamab + Teclistamab: https://doi.org/10.1182/blood.2024025939 postMONARCH: https://doi.org/10.1200/JCO-24-02086

We discuss recent approvals of ensartinib and nivolumab-hyaluronidase as well as new front-line option for BRAV-V600E mutated metastatic colorectal cancer.

Weighing the Pros & Cons of the accelerated approval pathway as it relates to oncology. An updated draft guidance document from FDA regarding this pathway and some compelling data regarding the public's perceived value of newly approved drugs for cancer. Article: Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment. Forest R, et al. Lancet Oncology 2024. Link: https://doi.org/10.1016/S1470-2045(24)00596-5

Looking back at new approvals from 2024 - what to keep, re-gift, or return? And yes, as soon as this was recorded 2 new drugs were approved.

Lots of recent clinical trial updates to discuss: AQUILA: Daratumumab for high-risk smoldering multiple myeloma Checkmate 8HW: Nivo/Ipi for MSI-high/MMRd metastatic colorectal cancer DESTINY-Breast06: T-DXd in HER2-low MBC after hormonal treatment, but without previous chemo for MBC ARMANI: Switch maintenance ramucirumab-paclitaxel in metastatic gastric/GEJ cancer HELEN-006: Neoadjuvant nab-paclitaxel/trastuzumab/pertuzumab vs. TCHP in breast cancer SONIA: finally published!

A first-in-class approval of a bispecific HER2-HER3 monoclonal antibody for NRG1 fusion (+) NSCLC and pancreatic cancer.

The 1st menin inhibitor, revumenib, is approved for relapsed/refractory acute leukemias. Understanding the Pathway: https://doi.org/10.1200/JCO-24-01265

A nice editorial succinctly summarizes a framework for thinking about how to incorporate anthracyclines into the treatment of early stage breast cancer patients. Anthracyclines in Early Breast Cancer: The Long Goodbye -https://doi.org/10.1200/JCO-24-01916 10-year Outcomes of READ trial: https://doi.org/10.1200/JCO.24.00836 Bonus - Practical Guide for Testing for Pharmacogenomics: https://doi.org/10.1200/OP.24.00191

Reviewing the data to support use of dexamethasone solution mouthwash for PIK3/AKT/mTOR inhibitor-induced stomatitis, caused by drugs like everolimus, alpelisib, capivasertib, & inavolisib. SWISH: https://doi.org/10.1016/s1470-2045(17)30109-2 Alliance MIST Trial: https://doi.org/10.1053/j.seminoncol.2023.01.001

The first Cldn 18.2 targeting monoclonal antibody has been improved. Let's talk about it!

Discussing two excellent articles from earlier this month. S1826: N-AVD vs. Bv-AVD (DOI: 10.1056/NEJMoa2405888) & INTERLACE: induction chemo prior to concurrent cisplatin/RT in locally advanced cervical cancer (DOI: https://doi.org/10.1016/S0140-6736(24)01438-7)

A new PIK3Ca inhibitor is approved for breast cancer.

Reviewing 3 recent AML publications Double-Dauno (90 mg/m2 vs. 60 mg/m2): https://doi.org/10.1200/JCO.24.00235 AML60+ Risk Stratification: https://doi.org/10.1200/JCO.23.02631 Decitabine-Ven as bridge to Allo HSCT: https://doi.org/10.1016/S2352-3026(24)00241-2

MSI-high/MMRd rectal cancer treatment guidelines are being re-written. A brief synopsis of why treatment guidelines are changing so quickly in this space. Also, listeners helped out in explaining the ribociclib storage & stability change. Hint: https://www.novartis.com/news/novartis-implements-manufacturing-adjustments-ribociclib-ensure-alignment-latest-regulatory-standards-ebc-end-q2