@pgrivasmdphd.bsky.social
23/🔑SUMMARY🔑
2L & later line tx in mUC
👉Erdafitinib FDA-approved w/ FGFR3 alt after prior tx
🎉NCCN guidelines updated Jan 2025
🔬Ongoing trials for SG in diff clin scenarios
✔️T-DXd for HER2 IHC3+ (based on gastric cancer scoring algorithm)
2L & later line tx in mUC
👉Erdafitinib FDA-approved w/ FGFR3 alt after prior tx
🎉NCCN guidelines updated Jan 2025
🔬Ongoing trials for SG in diff clin scenarios
✔️T-DXd for HER2 IHC3+ (based on gastric cancer scoring algorithm)
April 1, 2025 at 11:52 PM
23/🔑SUMMARY🔑
2L & later line tx in mUC
👉Erdafitinib FDA-approved w/ FGFR3 alt after prior tx
🎉NCCN guidelines updated Jan 2025
🔬Ongoing trials for SG in diff clin scenarios
✔️T-DXd for HER2 IHC3+ (based on gastric cancer scoring algorithm)
2L & later line tx in mUC
👉Erdafitinib FDA-approved w/ FGFR3 alt after prior tx
🎉NCCN guidelines updated Jan 2025
🔬Ongoing trials for SG in diff clin scenarios
✔️T-DXd for HER2 IHC3+ (based on gastric cancer scoring algorithm)
21/Why TROPiCS4 neg for OS?
Hard to est, consider:
🔸Late-line,hvly pretx pop
🔸Ltd primary G-CSF prophy in SG arm(~20%)
🔸~5% pts randomized to control never rec’d tx(~2% in SG arm)
🚫biomarker selection(UGT1A1 gene polym→⬆️tox?)
🔸~20% in each arm rec'd salvage EV(confounding)
Hard to est, consider:
🔸Late-line,hvly pretx pop
🔸Ltd primary G-CSF prophy in SG arm(~20%)
🔸~5% pts randomized to control never rec’d tx(~2% in SG arm)
🚫biomarker selection(UGT1A1 gene polym→⬆️tox?)
🔸~20% in each arm rec'd salvage EV(confounding)
April 1, 2025 at 11:52 PM
21/Why TROPiCS4 neg for OS?
Hard to est, consider:
🔸Late-line,hvly pretx pop
🔸Ltd primary G-CSF prophy in SG arm(~20%)
🔸~5% pts randomized to control never rec’d tx(~2% in SG arm)
🚫biomarker selection(UGT1A1 gene polym→⬆️tox?)
🔸~20% in each arm rec'd salvage EV(confounding)
Hard to est, consider:
🔸Late-line,hvly pretx pop
🔸Ltd primary G-CSF prophy in SG arm(~20%)
🔸~5% pts randomized to control never rec’d tx(~2% in SG arm)
🚫biomarker selection(UGT1A1 gene polym→⬆️tox?)
🔸~20% in each arm rec'd salvage EV(confounding)
20/ @Uromigos thoroughly addressed of sacitizumab govitecan TROPiCS-04 findings presented at #ESMOAsia
🎧Worth a listen 👉 bit.ly/UromigosEp371
#OncSky
🎧Worth a listen 👉 bit.ly/UromigosEp371
#OncSky
Episode 371: TROPICS-04 Results from ESMO Asia by The Uromigos
Jonathan Rosenberg joins Brian and Tom to discuss this important phase 3 trial and efficacy and toxicity signals.
bit.ly
April 1, 2025 at 11:52 PM
20/ @Uromigos thoroughly addressed of sacitizumab govitecan TROPiCS-04 findings presented at #ESMOAsia
🎧Worth a listen 👉 bit.ly/UromigosEp371
#OncSky
🎧Worth a listen 👉 bit.ly/UromigosEp371
#OncSky
19/TROPiCS-04
Ph3 RCT SG vs chemo in pretx mUC
🚫sig. improvmt in OS w/ SG compared to taxane or VIN
mOS: SG 10.3 vs chemo 9.0mo
(HR:0.86; 95% CI:0.73–1.02; p=0.087)
Grade ≥3️ TRAEs (SG): Neutropenia(35%; FN 12%), diarrhea (15%)
G5 AEs: SG 7% (16 inf w neutropenia), chemo 2%
Ph3 RCT SG vs chemo in pretx mUC
🚫sig. improvmt in OS w/ SG compared to taxane or VIN
mOS: SG 10.3 vs chemo 9.0mo
(HR:0.86; 95% CI:0.73–1.02; p=0.087)
Grade ≥3️ TRAEs (SG): Neutropenia(35%; FN 12%), diarrhea (15%)
G5 AEs: SG 7% (16 inf w neutropenia), chemo 2%
April 1, 2025 at 11:52 PM
19/TROPiCS-04
Ph3 RCT SG vs chemo in pretx mUC
🚫sig. improvmt in OS w/ SG compared to taxane or VIN
mOS: SG 10.3 vs chemo 9.0mo
(HR:0.86; 95% CI:0.73–1.02; p=0.087)
Grade ≥3️ TRAEs (SG): Neutropenia(35%; FN 12%), diarrhea (15%)
G5 AEs: SG 7% (16 inf w neutropenia), chemo 2%
Ph3 RCT SG vs chemo in pretx mUC
🚫sig. improvmt in OS w/ SG compared to taxane or VIN
mOS: SG 10.3 vs chemo 9.0mo
(HR:0.86; 95% CI:0.73–1.02; p=0.087)
Grade ≥3️ TRAEs (SG): Neutropenia(35%; FN 12%), diarrhea (15%)
G5 AEs: SG 7% (16 inf w neutropenia), chemo 2%
18/🔬TROPHY-U-01 Cohort 3 trial safety of sacituzumab govitecan👇
TRAEs led to➡️
✋SG interruptions in 46%
⬇️SG dose reduction in 39%
🛑SG d/c in 15%
@markuseckstein3.bsky.social @amandanizammd.bsky.social #OncSky
TRAEs led to➡️
✋SG interruptions in 46%
⬇️SG dose reduction in 39%
🛑SG d/c in 15%
@markuseckstein3.bsky.social @amandanizammd.bsky.social #OncSky
April 1, 2025 at 11:52 PM
18/🔬TROPHY-U-01 Cohort 3 trial safety of sacituzumab govitecan👇
TRAEs led to➡️
✋SG interruptions in 46%
⬇️SG dose reduction in 39%
🛑SG d/c in 15%
@markuseckstein3.bsky.social @amandanizammd.bsky.social #OncSky
TRAEs led to➡️
✋SG interruptions in 46%
⬇️SG dose reduction in 39%
🛑SG d/c in 15%
@markuseckstein3.bsky.social @amandanizammd.bsky.social #OncSky
17/#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
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
April 1, 2025 at 11:52 PM
17/#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
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
16/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
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
April 1, 2025 at 11:52 PM
16/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
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
15/🏁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
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
April 1, 2025 at 11:52 PM
15/🏁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
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
14/💡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?
🙌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?
April 1, 2025 at 11:52 PM
14/💡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?
🙌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?
11/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
#OncSky #BladderCancer
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
#OncSky #BladderCancer
April 1, 2025 at 11:52 PM
11/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
#OncSky #BladderCancer
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
#OncSky #BladderCancer
10/➡️Erdafitinib cont.
👍mOS and mPFS significantly ⬆️in erdafitinib group vs taxane or vinflunine
THOR1 trial efficacy results 👇
#OncSky @achoud72.bsky.social @pbarata95.bsky.social @crisbergerot.bsky.social @paulobergerot.bsky.social @alisonbirtle.bsky.social @laurabukavinamd.bsky.social
👍mOS and mPFS significantly ⬆️in erdafitinib group vs taxane or vinflunine
THOR1 trial efficacy results 👇
#OncSky @achoud72.bsky.social @pbarata95.bsky.social @crisbergerot.bsky.social @paulobergerot.bsky.social @alisonbirtle.bsky.social @laurabukavinamd.bsky.social
April 1, 2025 at 11:52 PM
10/➡️Erdafitinib cont.
👍mOS and mPFS significantly ⬆️in erdafitinib group vs taxane or vinflunine
THOR1 trial efficacy results 👇
#OncSky @achoud72.bsky.social @pbarata95.bsky.social @crisbergerot.bsky.social @paulobergerot.bsky.social @alisonbirtle.bsky.social @laurabukavinamd.bsky.social
👍mOS and mPFS significantly ⬆️in erdafitinib group vs taxane or vinflunine
THOR1 trial efficacy results 👇
#OncSky @achoud72.bsky.social @pbarata95.bsky.social @crisbergerot.bsky.social @paulobergerot.bsky.social @alisonbirtle.bsky.social @laurabukavinamd.bsky.social
8/Even w pembro➡️24 mo PFS rate in KEYNOTE-045 was 12.4%👉Pts likely to need subsequent line tx
🧐NCCN guidelines RE: next tx?
Options (if not given prior):
🔶EV
🔶Erda for FGFR3 alt
🔶T-DXd for HER2 IHC 3+ (gastric Ca scoring)
🔶Saci(indication withdrawn, still in NCCN gdlns)
🧐NCCN guidelines RE: next tx?
Options (if not given prior):
🔶EV
🔶Erda for FGFR3 alt
🔶T-DXd for HER2 IHC 3+ (gastric Ca scoring)
🔶Saci(indication withdrawn, still in NCCN gdlns)
April 1, 2025 at 11:44 PM
8/Even w pembro➡️24 mo PFS rate in KEYNOTE-045 was 12.4%👉Pts likely to need subsequent line tx
🧐NCCN guidelines RE: next tx?
Options (if not given prior):
🔶EV
🔶Erda for FGFR3 alt
🔶T-DXd for HER2 IHC 3+ (gastric Ca scoring)
🔶Saci(indication withdrawn, still in NCCN gdlns)
🧐NCCN guidelines RE: next tx?
Options (if not given prior):
🔶EV
🔶Erda for FGFR3 alt
🔶T-DXd for HER2 IHC 3+ (gastric Ca scoring)
🔶Saci(indication withdrawn, still in NCCN gdlns)
7/ IMvigor130 safety results 👇
🎯 Fewer AEs ➡️ withdrawal of any agent in atezo only group
🎯 Most common TRAEs mainly related to chemo
✓ Anemia
✓ Neutropenia
✓ Thrombocytopenia
#OncSky
🎯 Fewer AEs ➡️ withdrawal of any agent in atezo only group
🎯 Most common TRAEs mainly related to chemo
✓ Anemia
✓ Neutropenia
✓ Thrombocytopenia
#OncSky
April 1, 2025 at 11:44 PM
7/ IMvigor130 safety results 👇
🎯 Fewer AEs ➡️ withdrawal of any agent in atezo only group
🎯 Most common TRAEs mainly related to chemo
✓ Anemia
✓ Neutropenia
✓ Thrombocytopenia
#OncSky
🎯 Fewer AEs ➡️ withdrawal of any agent in atezo only group
🎯 Most common TRAEs mainly related to chemo
✓ Anemia
✓ Neutropenia
✓ Thrombocytopenia
#OncSky
6/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
@oncobellmunt.bsky.social @sandysrimd.bsky.social
✓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
@oncobellmunt.bsky.social @sandysrimd.bsky.social
April 1, 2025 at 11:44 PM
6/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
@oncobellmunt.bsky.social @sandysrimd.bsky.social
✓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
@oncobellmunt.bsky.social @sandysrimd.bsky.social
5/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)
@pcvblack.bsky.social #OncSky
✔️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)
@pcvblack.bsky.social #OncSky
April 1, 2025 at 11:44 PM
5/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)
@pcvblack.bsky.social #OncSky
✔️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)
@pcvblack.bsky.social #OncSky
4/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
#OncSky
✅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
#OncSky
April 1, 2025 at 11:44 PM
4/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
#OncSky
✅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
#OncSky
3/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)
#OncSky
👇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)
#OncSky
April 1, 2025 at 11:44 PM
3/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)
#OncSky
👇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)
#OncSky
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
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
April 1, 2025 at 11:38 PM
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
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
Reposted
Happy New Year from OncoAlert
@jrgralow.bsky.social
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@stoverlab.bsky.social
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January 1, 2025 at 5:17 AM