Oncopharmpod

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.

New OS data is out for adjuvant atezolizumab in NSCLC - how does it compare to the original DFS data? Plus, lots of recent FDA expanded approvals to discuss.

An infamous study that led to a drug approval of limited benefit, but still made its way into an episode of Better Call Saul. Erlotinib + gemcitabine vs. gemcitabine: https://doi.org/10.1200/jco.2006.07.9525

Several recent large trials just released long term follow-up results on overall survival. We look at what how treatment principles may change based on these mature data. ECHELON-1 - Hodgkin's (A+AVD vs. ABVD) POLO - Pancreatic (olaparib maintenance vs. placebo) Keynote 355 - mTNBC (pembrolizumab + chemo vs. chemo) APHinity - adjuvant HER+ breast (pertuzumab/trastuzumab vs. trastuzumab) E1912 - CLL (ibrutinib/rituximab vs. FCR)

Discussion with a Lupus Nephritis patient (and Pharm.D. student) about manifestations and treatments of SLE and Lupus Nephritis.

Sifting through and summarizing lots of data on concomitant use of ICIs and PPIs. Suggested readings: 1. All the drugs: https://pubmed.ncbi.nlm.nih.gov/33154150/ 2. Pooled atezolizumab study: https://pubmed.ncbi.nlm.nih.gov/35183773/ 3. Clostridium butyricum may be a thing: https://pubmed.ncbi.nlm.nih.gov/35655708/ 4. AKI risk: https://doi.org/10.21873/invivo.12570 5. Is this all noise?: https://pubmed.ncbi.nlm.nih.gov/35280736/ 6. Abx & PPIs: https://doi.org/10.3389/fimmu.2021.716317