Oncopharmpod

FDA has been busy the last week approving: -ribociclib x 3 years in high risk stage II & III breast cancer based on the NATALEE trial as well as a new storage requirement -osimertinib indefinitely following chemoradiation in stage III EGFR-mutated NSCLC -amivantamab + chemotherapy following progression on osimertinib (Mariposa-2) -a subcutaneous formulation of atezolizumab -isatuximab + VRD for multiple myeloma -pembrolizumab + chemotherapy for metastatic pleural mesothelioma

Recapping just some of the notable data coming out of ESMO 2024: -Final OS results from Keynote-522 (perioperative pembrolizumab in TNBC) -AMBASSADOR (adjuvant pembrolizumab in bladder cancer) -NIAGRA (perioperative durvalumab in bladder cancer) -ADRIATIC (discussed on ASCO recap Pod, but publication now available) -LEANOX (impact of lean body mass adjustment on oxaliplatin dose)

LMS04 final OS results are published for doxorubicin + trabectedin in Leiomyosarcoma. Plus, a natural experiment of what happens in small cell lung cancer during an IV etoposide shortage. Finally, a nice paper provides some examples of how oncology pharmacists can bridge the care gap between oncology and primary care. LMS04: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2403394 IV etoposide shortage: https://doi.org/10.1200/OP.24.00394 Primary care - oncology pharmacy collaboration: https://doi.org/10.1177/10781552241279303

This is chapter 1 of a keynote address from summer 2024 on putting together the pieces of oncology pharmacy - with an emphasis on how our knowledge of drug dosing changes with time. Video/slides available at YouTube: https://youtu.be/1Oae8AV5Af4

We all know we aren't supposed to make cross-trial comparisons, but it happens anyway. So, let's compare FLARUA2 (osimertinb + chemo) and the newly FDA-approved MARIPOSA regimen (lazertinib + amivantamab) to see what we can (and can't) take away from such a dangerous cross-trial comparison.

A mixed bag of Phase III results for using olanzapine with moderately emegotenic chemotherapy (MEC). Inui, et al: https://doi.org/10.1200/JCO.24.00278 Ostwal, et al: doi:10.1001/jamanetworkopen.2024.26076

A new cellular therapy is approved for synovial sarcoma and the anticipated approval has occurred for the dual IDH1/IDH2 inhibitor, vorasidenib.

FDA appears to change its stance on evaluating perioperative (adjuvant followed by neoadjuvant) ICI study designs in NSCLC. Also, a simple blood test is approved to detect colorectal cancer, but there are several limitations compared to colonoscopy.

Did you know high-dose chemotherapy with autologous stem cel rescue was a "standard" breast cancer treatment ~30 years ago? This story involves changing practices based on Phase II data and outright clinical trial fraud, and retractions of publications. On-site review of Bezwoda study: https://doi.org/10.1016/S0140-6736(00)90024-2 Oral History: https://cancerhistoryproject.com/institutions/nccns-bob-carlson-talks-about-the-day-he-stormed-out-of-a-meeting-with-transplanters/

Reflections from vacation on 1) How similar the chef training experience on The Bear mirrors some pharmacy residency training and 2) being a resource to family/friends with oncology questions.

Running through recent updates on epcoritamab, adagrasib + cetuximab for colorectal cancer, endometrial cancer, adjuvant dabrafenib/trametinib melanoma follow-up data, and topical capsaicin for delayed CINV. Also, a brief travelogue on my inaugural trip to ATOPP (advanced topics for oncology pharmacy professionals) Summit.

The MARIPOSA study suggests there may be a new preferred first line regimen (amivantamab + lazertinib) for metastatic EGFR-mutated NSCLC, as this regimen improved PFS compared to osimertinib.

An experimental regimen for DLBCL piques my interest. Venetoclax ibrutinib Prednisone Obinutuzumab Revlimid (lenalidomide) Link: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2401532

A new drug is approved for MDS. While some will likely benefit from this new agent, the more enticing news is that inhibiting telomerase may be an attractive target for many malignancies.

Lots and lots of updates from the past weekend's ASCO annual meeting. 1. ADRIATIC (consolidation durvalumab in limited stage SCLC) 2. NADINA (neoadjuvant Nivo/Ipi in stage III melanoma) 3. *NICHE-2 (neoadjuvant Nivo/Ipi in dMMR colon cancer) 4. CheckMate 8HW (Nivo/Ipi in dMMR metastatic colon cancer) 5. TRANSMET (liver transplantation in colon cancer with liver mets) 6. Eposec (FLOT > CROSS in adenocarcinoma of the esophagus) 7. LAURA (forever osimertinib in stage III EGFR-mutated NSCLC post-chemoRT) 8. CROWN (5 year update of lorlatinib in ALK+ NSCLC) 9. Destiny Breast-06 (T-DXd vs. chemo in HER-2 low and "ultra" low MBC who haven't received chemo in metastatic setting) 10. ASC4FIRST (Asciminib first line in CML. Funny title, amirite?)

ASCO & ONS (along with pharmacist representation) released updated safety standards for preparing, administering, and monitoring chemotherapy. Look for a calendar invitation to review your site's policies soon. Link: https://doi.org/10.1200/OP.24.00216

A new drug for small-cell lung cancer, a bispecific, targeting DLL3 on small-cell lung cancer and CD3 on T-cells is FDA approved. But, infigratinib's FDA approval for cholangiocarcinoma is withdrawn.

QT interval prolongation is a common hurdle to taking care of cancer patients. We dive into what QT interval prolongation is, why it matters, risk factors, and prevention/management strategies.

The non-Award Winning series of Landmarks in OncoPharm returns to discuss a Next Big Thing in NHL that wasn't any better than plain old CHOP. From April 1993, it's Pro-MACE-CytaBOM Link: https://www.nejm.org/doi/full/10.1056/NEJM199304083281404

Tisotumab vedotin garners a regular FDA approval for metastatic cervical cancer with OS benefit data. A lingering question that demands a focused RCT: What is the optimal dose of methotrexate in primary CNS lymphoma? I'm glad I'm not the only one with this question: https://doi.org/10.1177/10781552231176754 What, some BRAF mutations in colorectal cancer might respond to EGFR-mab therapy? https://doi.org/10.1200/OP.21.00160