OncoPharm

Melphalan flufenamide, a drug that makes tumor cell kinetics cool again, is our main topic. Also, brief updates on lorlatinib (ALK+ mNSCLC) and nivolumab/cabozantinib (mRCC).

Topics covered: 1. Trilaciclib's approval to minimize bone marrow suppression 2. Cemiplimab's approval for mNSLC with high PD-L1 expression 3. A brief anti-BCMA CAR-T phase II trial in multiple myeloma 4. Confirmation of enfortumab vedotin's benefit in metastatic bladder cancer 5. More of the same with lenvatinib + pembrolizumab in mRCC

Happy Birthday to a drug that ushered in its own era! We discuss its history and development and just a little bit about its benefit, role, and a few clinical pearls.

Discussing the latest TKI approval, umbralisib, and its familiar toxicity profile. Also, a few final words on a new CAR-T product and a cemiplimab expanded approval.

In light of teptinib's recent FDA-approval for exon-14 skipping MET altered metastatic NSLCC, we compare tepotinib to its predecessor in this space - capmatinib.

With the recent FDA-approval of nivolumab + cabozantinib for metastatic renal cell carcinoma (mRCC, we review Checkmate-9ER results and how they compare to other combination treatments in mRCC. We then end by discussion preliminary recommendations on vaccinating patients with cancer agains COVID-19. Checkmate-9ER abstract: https://oncologypro.esmo.org/meeting-resources/esmo-virtual-congress-2020/n...

Discussing recent FDA approvals for expanded indications for trastuzumab-deruxtecan for gastric cancer (based on DESTINY-Gastric01) and SC daratumumab for AL amyloidosis. DESTINY-Gastric01: https://www.nejm.org/doi/full/10.1056/NEJMoa2004413

Our landmarks of OncoPharm series returns to discuss JBR10, adjuvant cisplatin/vinorelbine in NSCLC. JBR10: https://www.nejm.org/doi/pdf/10.1056/NEJMoa043623 JBR10 Update: https://pubmed.ncbi.nlm.nih.gov/19933915/ LACE meta-analysis: https://pubmed.ncbi.nlm.nih.gov/18506026/

The 1st episode of 2021 covers 5 FDA updates from December 2020 -Pralsetinib for RET-mutated medullary thyroid cancer -The new HER2-targeting margetuximab -Selinexor and the Boston study -Relugolix, an oral GnRH antagonist -Adjuvant osimertinib approved (ADAURA)

Our Foundations of Oncopharm series returns to discuss the history and use of trastuzumab.

Highlighting some of the bright spots, oncopharm & otherwise, for our Holiday episode. Best new drug? Best study? Best movie to take my mind off of a pandemic? Enjoy this episode with a glass of Holiday Cheer.

COVID-19 Vaccines are here!!! Will they work in patients on chemo? What about immunotherapy? Without firm answers to such questions we might as well talk about mRNA vaccines, the breakout star of 2020.

First up we discuss RxPonder and what it adds to adjuvant treatment of breast cancer in the context of TailoRx. Then we discuss a recent study (https://jamanetwork.com/journals/jama/fullarticle/2774295)of additional capecitabine following adjuvant chemo in TNBC and what it adds in the context of CREATE-X.

Final OS results are now available for IDEA - 3 vs. 6 months of adjuvant chemotherapy for colon cancer: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30527-1/fulltext Keynote-177 (pembrolizumab for MSI-H/dMMR metastatic colorectal cancer) was presented at ASCO, but interim results are now published as well: https://www.nejm.org/doi/full/10.1056/NEJMoa2017699

The Landmarks in OncoPharm series returns to discuss the practice-changing CLOT trial of a LMWH vs. a vitamin K antatogist for treating cancer-associated VTE. CLOT: https://www.nejm.org/doi/full/10.1056/nejmoa025313

Pembro gets an approval for triple negative breast cancer with quite high PD-L1 expression based on Keynote-355 (https://ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.1000). Some reassuring information on TKI discontinuation in CML from the LAST study (doi:10.1001/jamaoncol.2020.5774) and an interesting method of identifying predictors of TKI adherence in CML (https://journals.sagepub.com/doi/pdf/...

Our Landmarks of OncoPharm series returns with Ifosfamide

The BELLINI trial of venetoxlax in multiple myeloma was put on hold last year due to increased mortality. It's now published (https://doi.org/10.1016/S1470-2045(20)30525-8), so we take a look at the data and the myriad of supportive care concerns.

Discussing three recent publications: 1. Updated results of Keynote-426 (https://doi.org/10.1016/S1470-2045(20)30436-8) 2. Ph+ ALL tx with dasatinib/prednisone --> blinatumomab (https://www.nejm.org/doi/full/10.1056/NEJMoa2016272) 3. Decitabine + G-CSF to prevent AML relapse following alloHSCT (https://ascopubs.org/doi/pdf/10.1200/JCO.19.03277)

Another month, another 2 expanded FDA-approvals: nivolumab/ipilimumab for malignant pleural mesothelioma and pembrolizumab for relapsed/refractory classical Hodgkin's lymphoma.

Fulvestrant's standard dosing is now 500 mg IM on Days 1, 14, 29 & then monthly thereafter. Its initial FDA-approved doing was half that with no loading dose, 250 mg IM monthly. So, how did we come to underdose an antineoplastic for almost a decade?

Foundations in #OncoPharm returns to discuss everyone's favorite antineoplastic, dexamethasone, which is also an anti-emetic, and an oncology pre-med among other things.

Another week, another 2 studies of checkpoint inhibitors in NSCLC to talk about. IMpower 110: https://www.nejm.org/doi/full/10.1056/NEJMoa1917346 Checkmate-153: https://ascopubs.org/doi/full/10.1200/JCO.20.00131

Updates from ESMO 2020 & more on: Bladder Cancer (JAVELIN Bladder 100 & DANUBE) Lung Cancer (ADAURA & CROWN) Breast Cancer (ASCENT, IMPASSION 130/131, monarchE) And the first major publication of drugging the "undrugable" KRAS

The Landmarks in OncoPharm series returns to discuss a major breakthrough in treating advanced prostate cancer, TAX-327, which at the time established docetaxel as a new standard of care for metastatic prostate cancer that was (at that time) considered hormone-refractory. TAX 327: https://www.nejm.org/doi/full/10.1056/NEJMoa040720