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Best practices for 2L+ tx #MetastaticUrothelialCarcinoma 🧵 w Tian Zhang, MD, MHS & me ...assuming EV+P 1L ✅FGFR3 alts: THOR/erda 🎯Trop-2: sacituzumab govitecan 🏁HER2 IHC 3+: T-DXd Support by edu grants: Astellas, Gilead Sci, Merck, Seagen CMEℹ️@BonumCE👇 What’s your specialty?

2/ 📸👇COI & CME info👇 Full #CME ℹ️ bit.ly/muc_tw2 1️⃣ Answer Pre-survey 👉 bit.ly/muc_tw2_pre 2️⃣ Review #MedTweetorial👇 3️⃣ claim CME🏆bit.ly/muc_tw2_post #MedTwitter #OncTwitter #gucsm #BladderCancer #MetastaticUrothelialCarcinoma #OncX #CommunityOncology

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD 4/Chemo-naive cisplatin eligible pts 👇Post-1L IO monotx👇 💡2L gem+cisplatin (or ddMVAC) pref'd 💡Erda for FGFR3 mut/fusion (THOR level 1 evidence for erda post-IO) 👉Cisplatin ineligible pts can get gem+carbo or EV (or erda if FGFR3+ alt)

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD 5/Let’s consider a pt case... 74yo F s/p gem/ + cisplatin Avelumab maintenance x12m 🧬No FGFR3 alterations, HER2 IHC 0 🆕liver mets 🟢What would you do next? Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS 6/Preferred 2L tx for cisplatin-ineligible pts after 1L ICI monoTx ✅EV or ➡️gem + carbo or ➡️erdafitinib (if FGFR alt+) 👉Pembro alone is one of2L tx options for pts who progress after 1L platinum-based chemo and have not received ICI Daniel Petrylak Howard Gurney Alessandro Volpe

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe 7/Other 2L options(depending on prior tx): ✔️Erda for FGFR3 alterations ✔️EV monotx Taxane if no access to☝️ ✔️Nivo or avelumab if no access to pembro + ICI naïve ✔️T-DXd for HER2 3+ IHC (gastric Ca scoring) ✔️Sacituzumab govitecan (FDA indication withdrawn) Peter Black Yohann Loriot

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot 8/Atezolizumab EMA approved as monotx ✓1L in cisplatin-ineligible + PD-L1 +ve Based on IMvigor 210 & 130 trials 🔬IMvigor 130: ✅mPFS significantly longer in atezo+plat/Gem vs plat/Gem alone 🚫mOS not sign. longer in atezo grps vs plat/Gem alone #OncTwitter #OncX

Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Jean Hoffman-Censits Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 13/Erda. Safety Grade ≥3 TRAEs occurred in 45.9% w erdafitinib & 46.4% w chemo ⚖️Most AEs w erdafitinib manageable w dose modification & best supportive care 🛑Tx d/c rates 8.1% w erdafitinib & 13.4% w chemo #OncTwitter #BladderCancer

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 14/🟢When managing possible AEs with erda, what would you do next for this patient... 67yo M s/p 1L EV + P 🧬+ FGFR3 alteration Tx w 2L erdafitinib Serum phosphate 8.0 mg/dL

Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Jean Hoffman-Censits Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 14/🟢When managing possible AEs with erda, what would you do next for this patient... 67yo M s/p 1L EV + P 🧬+ FGFR3 alteration Tx w 2L erdafitinib Serum phosphate 8.0 mg/dL

Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Jean Hoffman-Censits Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 15/💡For phosphate of 8.0 mg/dL, withhold erdafitinib & restart once phosphate <5.5 mg/dL 🙌Erdafitinib=good option for pts w susceptible FGFR3 alt ⚖️What about pts who progress after 1L tx & no FGFR3alt? ⚖️How does the changing 1L tx landscape w EV+P affect choice of 2L tx?

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 15/💡For phosphate of 8.0 mg/dL, withhold erdafitinib & restart once phosphate <5.5 mg/dL 🙌Erdafitinib=good option for pts w susceptible FGFR3 alt ⚖️What about pts who progress after 1L tx & no FGFR3 alt? ⚖️How does the changing 1L tx landscape w EV+P affect choice of 2L tx?

Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Jean Hoffman-Censits Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 16/🏁What about T-DXd in mUC? 1st tumor agnostic ADC w FDA approval for Tx-refractory HER2+ IHC3+ Cas From DESTINY-PanTumor02 16 pts w/ HER2 IHC3+ mUC 56.3% ORR, mPFS 7.4mo, mOS 13.4mo No significant neuropathy 🔑AEs: pneumonitis, neutropenia, N/V, left ventricular dysfunction

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 16/🏁What about T-DXd in mUC? 1st tumor agnostic ADC w FDA approval for Tx-refractory HER2+ IHC3+ Cas From DESTINY-PanTumor02 16 pts w/ HER2 IHC3+ mUC 56.3% ORR, mPFS 7.4mo, mOS 13.4mo No significant neuropathy 🔑AEs: pneumonitis, neutropenia, N/V, left ventricular dysfunction

Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Jean Hoffman-Censits Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 17/Sacituzumab govitecan(SG) an ADC 🎯Trop-2 An active agent in mUC but failed to show stat. significant longer OS over taxane or vinflunine (VIN) in TROPiCS-04 ✅FDA approval w/drawn~Oct 2024 👉Let’s look @ original approval & possible reasons for a negative P3 trial

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 17/Sacituzumab govitecan(SG) an ADC 🎯Trop-2 An active agent in mUC but failed to show stat. significant longer OS over taxane or vinflunine (VIN) in TROPiCS-04 ✅FDA approval w/drawn~Oct 2024 👉Let’s look @ original approval & possible reasons for a negative P3 trial

Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Jean Hoffman-Censits Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 18/#TROPHYU01 Cohorts 1,2,3👇 1️⃣=113 pts who progrs'd after plat chemo+ICI ✅Notable efficacy compared to hist cntls Led to accel approval 2021 2️⃣=38 cisplatin-inelig pts s/p ICI tx ✅ORR=32% 3️⃣= 41 pts who progrs'd after plat chemo w 2L SG+pembro ✅ORR=41% mPFS=5.3m mOS=12.7m

Thomas Flaig Jean Hoffman-Censits Elizabeth Plimack MD Ravindran Kanesvaran Vadim Koshkin MD Matt Milowsky Yuji Miura Jonathan Rosenberg MD 𝐂𝐡𝐚𝐧𝐝𝐥𝐞𝐫 𝐏𝐚𝐫𝐤 𝐌𝐃 𝐅𝐀𝐂𝐏 Javier Puente Sarah P. Psutka MD MS Daniel Petrylak Howard Gurney Alessandro Volpe Peter Black Yohann Loriot Andrea Necchi Sandy Srinivas Ian Davis joaquim bellmunt Matt Galsky Enrique Grande Tom Powles Fabio Schutz Michiel van der Heijden Ugo De Giorgi Earle Burgess Robert Huddart💙 Ben Tran Prof Ananya💙 @achoud72.bsky.social Neeraj Agarwal, MD, FASCO Andrea Apolo, M.D. Arun Azad Pedro C Barata, MD MSc FACP Stephanie Berg Cristiane D Bergerot Paulo G Bergerot 💙alison birtle Laura Bukavina 18/#TROPHYU01 Cohorts 1,2,3👇 1️⃣=113 pts who progrs'd after plat chemo+ICI ✅Notable efficacy compared to hist cntls Led to accel approval 2021 2️⃣=38 cisplatin-inelig pts s/p ICI tx ✅ORR=32% 3️⃣= 41 pts who progrs'd after plat chemo w 2L SG+pembro ✅ORR=41% mPFS=5.3m mOS=12.7m

Ab#4518 ASCO #ASCO25 by Andrea Necchi 👉 bit.ly/43HuZI7👉Ph2 SURE-02 trial of neo-adj SG-pembro --> adj pembro in pts w/ MIBC #bladdercancer 👉clinical CR in ~39% of pts, allowing bladder preservation👇Francesco Montorsi Chiara Mercinelli Valentina Tateo OncoAlert UroToday.com

Belzutifano é aprovado pelo FDA para tratamento de feocromocitoma e paraganglioma em adultos e adolescentes No LITESPARK-015, a TR foi de 26% e a DRm de 20,4m, com 32% apresentando redução de ≥50% em ≥1 anti-hipertensivo Fabio Schutz Rodrigo Coutinho Mariano mocbrasil.com/blog/tumores-n…