Oncopharmpod

New Year - New Drug, mosunetuzumab (a CD3-CD20 T-cell engager) is approved for r/r Follicular Lymphoma. And an intriguing retrospective cohort study found a higher rate of neutropenia with same-day pegfilgrastim in patients receiving dose-dense AC. Link: https://doi.org/10.1177/10781552221148116

This gift-giving season, we ask whether we want to Keep, Re-gift, or Return new oncology drugs approved this past year.

The FDA's pilot program, project renewal, uses capecitabine for its first label makeover. What's new & what are the possible implications of the DPYD warning now in the prescribing information?

Thought on: Double Dauno, but they said it better --> (https://open.spotify.com/episode/0eHEl3bUdZdg3mynUiNMG6?si=88cdab4b882e4667) Blinatumumab FTW The end of "the" neutropenic diet?

Tumor-Infiltrating Lymphocytes (TILs) getting closer to entering practice. Updated survival results published from DESTINY-Breast03 (T-DXd vs. T-DM1). A new IDH1 inhibitor, olutasidenib, is FDA-approved for relapsed or refractory AML.

Recent voluntary withdrawals from the US market of belantamab-mafodotin and atezolizumab's indication for bladder cancer have us weighing (again) the pros & cons of the accelerated approval program. Also, FDA approves the 1st fecal transplant product.

A new antibody-drug conjugate is approved for ovarian cancer.

We review the 5-year update of CheckMate 227 and the POSEIDON to generate the hypothesis that CLTA-4 inhibition has a role in PD-L1 negative metastatic NSCLC. CM 227 update: https://pubmed.ncbi.nlm.nih.gov/?term=36223558 POSEIDON: https://pubmed.ncbi.nlm.nih.gov/?term=36327426 Editorial: https://pubmed.ncbi.nlm.nih.gov/?term=36331243

The International Nonproprietary Names (INN) unit from WHO decided to drop the -mab suffix from new drug names. Instead, -tug, -bart, -ment, and -mig will be used. We have some thoughts. INN Report: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122354/#

New Drug Approvals! -Tremelimumab, the 2nd CTLA-4 inhibitor, finally gets approved. -Teclistamab, an excited BCMA-CD3 T-cell engager for multiple myeloma.

Landmarks of OncoPharm episode on maintenance pemetrexed in NSCLC. Switch maintenance: https://doi.org/10.1016/s0140-6736(09)61497-5 Continuation maintenance (PARAMOUNT): https://doi.org/10.1016/S1470-2045(12)70063-3

We discuss a phase I study (CALM) of an allogeneic anti-CD19 CART-T product, using aprepitant (?) for pruritis from EGFR TKIs, and the widely discussed NordICC study on colonoscopy screening. CALM: https://doi.org/10.1016/S2352-3026(22)00245-9 Aprepitant vs. desloratidine: https://doi.org/10.1002/cncr.34474 NordICC: https://www.nejm.org/doi/full/10.1056/NEJMoa2208375 NordICC editorial: https://www.nejm.org/doi/full/10.1056/NEJMe2211595

A new FGFR inhibitor, futibatinib, is approved. Is ESR1 mutation monitoring the next thing in HR+ metastatic breast cancer? The PADA-1 trial offers insight. What the heck is GPRC5D (rhymes with CAR-T)? PADA-1: https://doi.org/10.1016/S1470-2045(22)00555-1 GPRC5D CAR-T in Myeloma: https://www.nejm.org/doi/full/10.1056/NEJMoa2209900

Sodium thiosulfate is now FDA-approved to minimize the risk of ototoxicity in some children receiving cisplatin. Selpercatinib is granted a 'regular' approval for RET-fusion (+) NSCLC and an accelerated approval for other solid tumors.

Happy 9,22 day!

ESMO 2022 is wrapped and two studies in particular have caught our eyes: NICHE-2: neoadjuvant Nivo/Ipi in MMR-d colon cancer CODEBREAK: sotorasib vs. docetaxel

Updates on billiary track cancer - a role for durvalumab? And pemigatinib - an approval in r/r myeloid/lymphoid neoplasms. Plus, an oral suspension of ibrutinib is approved and more evidence ICI combination should be given early in BRAF-mutated metastatic melanoma (rather than waiting until disease progression on TKIs)

The Landmarks of OncoPharm series return to discuss the now standard-of-care temozolomide + RT for glioblastoma multiforme (GBM) Stupp et al: https://www.nejm.org/doi/full/10.1056/NEJMoa043330 Effect of MGMT (the gene, not the band) on temozolomide effect (from the same NEJM issue) referenced, thought not discussed in this episode: https://www.nejm.org/doi/full/10.1056/NEJMoa043331

Dr. Amir Ali joins the Pod to cover the Foundations of OncoPharm on asparaginase products

In light of trastuzumab deruxtecan's approval for HER-mutated NSCLC, it's worthwhile to look back at the history of HER-targeted therapy in NSCLC and why/how targeted HER-mutated disease will affect practice.