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How exactly does one “manage” a grade 5 toxicity?

💊 P1003 is the same payload used in DB-1303/ BNT323. Most of the other Duality's ADCs use P1021 instead. P1003 was disclosed in INN list #131 (see: pamirtecan). P1021 is still undisclosed, but likely as below (from patents). All exatecan derivatives (DXd and Ed-04 as ref.)

T-DXd has shown tremendous activity in trials. But how does it perform in the real world? What is its activity in pts with BRCA+, PDL1+ dz, or prior SG? We joined forces with Yale University to address this question in one of the largest studies to date (n=~1500).🧵 esmoopen.com/article/S2059-…

4/6 About half of the patients with mTNBC had received SG prior to T-DXd. These patients experienced much worse rwPFS and OS, whereas those without prior SG experienced a similar rwPFS with T-DXd to that reported in DB04. Confirms some degree of cross-resistance bw TOPO1 ADCs.

Great questions. We conducted a separate analysis of outcomes post-T-DXd by MBC subtype, presented at #SABCS24 and currently under review. We found that SG does not work that well after T-DXd (rwPFS ≤ 3 months), irrespective of intermediate chemo vs. sequenced immediately.

DB-1303/BNT323 (aka trastuzumab pamirtecan) is currently in phase 3 The trial names were very bold: "DYNASTY-Breast01" (DB-1303 vs T-DM1 in patients with HER2+ BC, NCT06265428) "DYNASTY-Breast02" (DB-1303 vs Investigator's Choice in patients with HER2-Low, HR+ BC, NCT06018337)

Syed A. Ahmad The benchmark for a carefully selected phase 1/2 population should not be the large multi center phase 3 survival data, but the commensurate carefully selected phase 1/2 of the control arm. For Gem/Abraxane the 6 month overall survival in phase 1/2 was not 67% but upwards of 85%

A B7H3-targeting ADC in advanced solid tumor Nature Medicine doi.org/10.1038/s41591… 🔎phase 1/1b trial, 312 pts 👉High ORRs: ES-SCLC: 63.9%, NPC: 48.6%, lung adenocarcinoma: 28.6% 👉No correlation btw B7H3 expression & ORR 🧐 Looks promising, more ADCs to come... ESMO - Eur. Oncology

Impact of Lean Body Mass–Based Oxaliplatin Dose Calculation on Neurotoxicity in Adjuvant Treatment of Stage III Colon Cancer: LEANOX Trial 💥Oxaliplatin dosing based on lean body mass reduces neuropathy without compromising survival (#ESMO24) ascopubs.org/doi/10.1200/JC…

By 2030, there will be at least one topo-1 ADC approved for most tumor types. Similar to what happened over the last decade with PD(L)1 inhibitors. 🌊

Dato-DXd now approved for patients with EGFR-mutated NSCLC after EGFR-directed & platinum-based therapies! Accelerated approval based on TROPION-Lung05 and TROPION-Lung01 ORR was 45% (95% CI: 35, 54) and median DOR was 6.5 months (95% CI: 4.2, 8.4)

The ADC era deepens: FDA grants accelerated approval. Dato-DXd is now approved for EGFR-mutant NSCLC after prior EGFR-targeted therapy and platinum-based chemo👇

HER2 IHC 3+ testing in 65,000+ solid tumors shows a 3.1% positivity rate Most common➡️Bladder (13.9%), uterine serous (13.6%), GEJ (12.1%). Least common➡️Glioma, sarcoma, SCLC(0%) 📌Bx and resection samples yield largely similar HER2 positivity rates jamanetwork.com/journals/jamao…

Randomized phase 2 trial of neoadjuvant ARX788 (anti-microtubule HER2 ADC) + pyrotinib vs TCHP for HER2+ BC (n=136). pCR rate 70% vs 51% (p=0.02). Poor tolerability of the ADC combo, with 99% diarrhea, frequent liver disfunction, 43% ILD, 75% ocular tox. nature.com/articles/s4146…

🇨🇳 Biokin Pharma (#SystImmune) announced that its EGFR/HER3 #ADC, iza-bren (BL-B01D1), achieved the primary endpoint in the interim analysis of a Ph3 clinical trial (BL-B01D1-303) for the treatment of nasopharyngeal carcinoma.

First positive phase 3 trial for a bispecific ADC (EGFR/HER3 topo1 ADC), co-developed by BiokinPharma & BMS. Bispecific ADCs are coming! fiercebiotech.com/biotech/biokin…

Amazing night (and photos)! Here my reaction at Alice Ruo Wei Tang telling me that mojitos are finally back after a decade on the sidelines. Kinda like ADCs.

Since 2003, we've invested over $65M to support visionary scientists in brain cancer research. We're inspired not only by their work, but by the powerful community and collaboration they've built together.

FDA grants accelerated approval to sunvozertinib (200mg po qd) for EGFR exon 20 insertion NSCLC after chemotherapy. In WU-KONG1B, RR 46%, mDOR 11.1m - important AEs include ILD, diarrhea, rash. Welcome addition with several others also in development. fda.gov/drugs/resource…

Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study - Journal of Thoracic Oncology #LCSM SmallCellSMASHERS jto.org/article/S1556-…