Shots:
AstraZeneca announced that tozorakimab met the 1EP in the P-III (MIRANDA) study, significantly reducing annualised rate of moderate-to-severe COPD exacerbations across pts. with COPD that still experiencing exacerbations while on inhaled SoC
In study pts. (n=1,454) received tozorakimab 300mg or PBO on top of SoC once every two weeks, including former and current smokers,…
Shots:
EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors
The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer
Preclinical data showed robust anti-tumor activity across…
Shots:
Eli Lilly reported positive topline results from the P-III (ACHIEVE-4) study of Foundayo (orforglipron) vs insulin glargine in ~2,700 pts with type 2 diabetes, and obesity or overweight with elevated CV risk, meeting the 1EP of non-inferiority in MACE-4 events
Foundayo demonstrated a 16% lower risk of MACE-4 and 23% lower risk of MACE-3,…
Shots:
Radiopharm Theranostics has reported that the final patient has been dosed in its US P-IIb imaging trial of RAD 101, evaluating recurrent brain metastases in patients with solid tumors. 1EP readout is expected in Jun’26, with plans to advance RAD 101 into a US P-III pivotal trial
The P-IIb trial is assessing 18F-RAD101 in…
Shots:
SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progression
Trial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along…
Shots:
The P-III (BRUIN CLL-322) trial assessed Jaypirca + venetoclax & rituximab vs venetoclax & rituximab in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), with both arms treated ~2yrs. followed by therapy-free period until disease progression
The trial met its 1EP, demonstrating improved PFS per IRC, with consistent results across clinically relevant subgroups…
Shots:
BioNTech reported positive results from a P-II study cohort of trastuzumab pamirtecan (BNT323/DB-1303) in HER2-expressing recurrent endometrial cancer, meeting its 1EP of ORR
The study cohort (n=145) demonstrated a confirmed ORR of 47.9% (n=96; central testing) and 49.3% in pts. (n=73) previously treated with checkpoint inhibitors, with a mPFS of 8.1mos., showing consistent efficacy…
Shots:
Vanda Pharmaceuticals has initiated the Thetis study assessing Nereus (tradipitant) vs PBO for the prevention of vomiting in pts receiving GLP-1 receptor agonist therapies
The Thetis study will assess the proportion of pts free from vomiting episodes as the 1EP, with Vanda expecting topline results by Q4’26 & noting that additional data may be…
Shots:
Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy
At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…
Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease
Shots:
Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED)
The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…

