Medical Oncologist @iov_irccs | PhD student @UniPadova | Proud #cysticfibrosis patient
Padova, Veneto
Joined February 2012
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Federico Nichetti retweeted
Every company developing G12X drugs should pay attention to this data at #ESMO26
Zecdarasib (G12Di) plus chemo in 1L metastatic PDAC, phase 1
ORR 89% with mFOLFIRINOX (n=27)
ORR 69% with gem/nab-paclitaxel (n=26)
Awesome safety for early DE.
For context, other early 1L PDAC response rates (cross-trial which we would neeeeever do):
Zoldonrasib + FOLFIRINOX: 82%
Zoldonrasib + gem/nab-P: 61%
Daraxonrasib + gem/nab-P: 59%
Daraxonrasib alone: 47%
Chemo clearly still matters. Starting to think about this like Breakwater…
In PDAC, monoallelic inhibitors are extremely effective, just more effective with a little extra oomph behind them.
They will land in adjuvant, neoadjuvant, metastatic and every space you can imagine in the next few years.
Question is do we combo single plus pan or single plus chemo, and what is the added agent (especially in CRC)?
@OncoAlert @TheGutOncLab @Onco_Nexus @Incyte
Federico Nichetti retweeted
Perioperative chemotherapy and stereotactic body radiotherapy versus perioperative chemotherapy alone in patients with high-risk, localised pancreatic cancer (MASTERPLAN): an open-label, phase 2, multicentre, randomised trial of the Australasian Gastro-Intestinal Trials Group
#cancer #oncology #MedX #ESMO26 @OncoAlert
thelancet.com/journals/lanon…
Federico Nichetti retweeted
🔥Ph2 Peri-operative RASi (HRS-4642, G12D)+ GnP +/-adebrelimab (PD-L1)
➡️two cohorts n=60 #PDAC
➡️safety- mainly haem, none precluded surgery
➡️ORR 63% & 87%;MPR in 17%
➡️R0 resection rate 100%
✅6 mth EFS rate 87% & 96%
➡️100% ⬇️CA19.9; OS pending
@myESMO #ESMO26 @OncoAlert
Federico Nichetti retweeted
INCB161734 KRASG12D (ON/OFF) + GnP or mFFX; updated ph1, n=53
➡️mostly GI toxicity,dose intensity 85% with GnP & 77%mFFX
✅ORR 69%, DCR 96% GnP
✅ORR 89%, DCR 100% mFFX
➡️6 mth PFS rates 80% & 90%
⭐️impressive & can combine mFFX
✅DAWN-303 ph3 ongoing
@myESMO #ESMO26 @OncoAlert
Federico Nichetti retweeted
Impressive results:
KRASCENDO-1 Phase III Divarasib vs. Sotorasib vs. Adagrasib (N= 338) for KRAS #G12C MT #NSCLC #lungcancer 🫁
- 30% had a history of treated brain met
- majority had received Sotorasib
🔹Primary PFS: 9.8 vs. 5.7M; HR = 0.58
🔹Secondary OS: 17.7M vs. 12M (HR = 0.56)
🔹ORR: 58% vs. 32%
#cancerresearch @OncoAlert #cancer @Roche #ESMO2026
Federico Nichetti retweeted
GFH276 pan-RAS (ON) molecular glue
➡️ph1/1b data; n=73 PDAC ,5-320mg
➡️no . prior lines tx =2
➡️ORR 41% in #PDAC, @ 40-160mg,
small nos with prior RASi
➡️Rash most common AE
As many trials move quickly to 1st line, how will we sequence??
@myESMO #ESMO26 @OncoAlert
Federico Nichetti retweeted
🔥HARMONi-GI1 ph3 advanced #BTC
➡️ivonescimab/GC v durva/GC mFU 14.3mths; China only & interim
✅ iCCA 58% ORR 53.8v32.5%; mPFS 8.4 v 5.8mths
✅mOS 14.9 v12.1mths HR0.75
➡️AE rate high in both
Control arm OS represents❗️VEGF in BTC ⭐️ looks promising
@myESMO #ESMO26 @OncoAlert
Federico Nichetti retweeted
Encorafenib plus cetuximab beyond progression in combination with FOLFIRI in BRAF V600E mCRC progressing on EC: Results from the ECLYPse phase II trial
#ESMO26 #ESMOAmbassadors
👉 mPFS: 7.1
👉 mOS: NR
👉ORR 15%
🧐Interesting signal to continue EC, more translational data would be great
@myESMO @ASCO
Federico Nichetti retweeted
ACTICCA-1 trial: Adj. GemCis vs standard of care after curative intent resection of BTC
#ESMO26 #ESMOAmbassadors
👉 DFS at 2yrs: 52 vs 44%
👉mDFS: 23.3 vs 20.6
👉 mOS: 58 vs 48 mo
👉expected toxicity for the doublet
🧐 Trend for OS benefit, not an option for all, but may be considered as option for selected pts
@myESMO @ASCO
Federico Nichetti retweeted
TRIDENTE: A phase II study of rechallenge with ENCO, BINI, and CET in BRAF V600E-mutant mCRC
#ESMO26 #ESMOAmbassadors
👉mPFS: 2.8 mo
👉mOS: 9.6 mo
👉ORR: 19%
🧐Supports biomarker-driven re-challenging concepts for 🎯therapies in CRC
@myESMO @ASCO
Federico Nichetti retweeted
G-HOPE-001 phs-3: Arcotatug tavatecan vs TPC in previously treated G/GEJA: First interim analysis
#ESMO26 #ESMOAmbassadors
🇨🇳🇯🇵, 2600 prescreened, 430 included
👉ORR: 37 vs 7.7%
👉 mPFS: 7.1 vs 3.1 mo
👉 mOS: 10.2 vs 6.9 mo
🧐CLDN-2 ADC, strong signal of efficacy, acceptable safety
@myESMO @ASCO
Federico Nichetti retweeted
RASolute 302 ph3 study: Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated mPDAC
#ESMO26 #ESMOAmbassadors
👉 mOS: 13.2 vs 6.7 mo
👉ORR improved in all RAS mutations
👉PFS & OS: small subgroups, favourable for all
🧐great data, consistent benefits for all pts
@myESMO @ASCO
Federico Nichetti retweeted
MASTERPLAN randomised ph2
➡️chemo(90% mFFX) +\-SBRT localised #PDAC
➡️included potentially operable high risk /BR &LAPC not operable
➡️primary endpoint 12mth LRR :20% v 52%
➡️more R0 resections with SBRT
➡️mPFS 11.9 v6.3mth; mOS 22 v 14mth
@myesmo #ESMO26 @oncoalert
Federico Nichetti retweeted
Tango reports 82% tumor response rate in trial of combo therapy (Daraxonrasib plus vopimetostat) for advanced #PancreaticCancer at #ESMO26
statnews.com/2026/10/23/esmo…
Reduced toxicity data is particularly important as a lower Daraxonrasib dose can be used.
Federico Nichetti retweeted
#ESMO26 🚀 RASolute 302 | Phase III
👥 500 pts | Previously treated mPDAC
💊 Daraxonrasib (RAS(ON) inhibitor) vs chemo
📈 OS: 13.2 vs 6.7 mo (HR 0.40)
🧬 OS benefit by RAS genotype:
🔹 G12D: HR 0.49
🔹 G12V: HR 0.32
🔹 G12R: HR 0.61
📊 PFS: HR 0.55 (BICR)
🎯 ORR: 32% vs 11%
💡 new SOC!
@OncoAlert
Federico Nichetti retweeted
AMPLIFY-7P ph 2 study: Seven-valent mKRAS-specific lymph node targeted amphiphile immunotherapy versus observation in resected PDAC)
#ESMO26 #ESMOAmbassadors
👉 Targeting lymph nodes to activate T-cells
👉T-cells response in 99% of pts
👉poor outcome in ctDNA pos pts
🧐promising data, specifically in pts with Tcell response
@myESMO
Federico Nichetti retweeted
Pancreatic Adenocarcinoma, Version 4.2026: NCCN Clinical Practice Guidelines in Oncology
🎯Tumour NGS is recommended for every patient who is a candidate for anticancer therapy, with RNA sequencing added because it detects fusions better.
- Neoadjuvant PAXG is listed as a useful-in-certain-circumstances option on the Italian Phase 3 result against mFOLFIRINOX (median EFS 16.0 vs 10.2 months, HR 0.63).
⚠️After neoadjuvant therapy, resection decisions are now framed by biological response (RECIST, CA 19-9, clinical status) rather than vascular contact alone.
🩸 The panel declines to make a consensus recommendation on postoperative ctDNA.
#NCCN #GIOnc #PDAC
jnccn.org/view/journals/jncc…
Federico Nichetti retweeted
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for our multi-selective RAS(ON) inhibitor for adults with metastatic pancreatic cancer in the EU.
Read more: revmed.com/media/news/13621/…
#ForMediaOnly
