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Fierce Pharma Asia—AZ, Daiichi's TROP2 readout; Padcev's bladder cancer win; AbbVie, I-Mab's CD47 breakup
Phase 3VaccineClinical Result
Positive phase 3 readouts from AstraZeneca and Daiichi Sankyo's Dato-DXd along with the Padcev-Keytruda combo made our news this week.
Dato-DXd, the TROP2-targeted anAstraZeneca conjDaiichi Sankyoopment by AstraZeneca and Daiichi Sankyo, has hits its goal in a breast cancer trial. Plus, the combination of Padcev and Keytruda succeeded in a broad first-line bladder cancer setting. AbbVie has officially terminated its CD47 collaboration with I-Mab. And more.
Dato-DXdZenecaTROP2-targetedfirst goal in pivotal breast cancer ADC triAstraZenecaup fiDaiichi Sankyoenge Gileadbreast cancerPadcevKeytrudabladder cancerAbbVieCD47
AstAstraZenecad Daiichi Sankyo’s datopotamab deruxbreast cancerten chemotherapy at delaying disease progreGileador death in previously treated HR-positive, HER2-low or negative breast cancer in a phase 3 trial. The drug also showed a favorable trend toward life extension, although the data were immature on that marker. If approved, the drug would compete with Gilead Sciences' anti-TROP2 antibody-drug conjugate Trodelvy.
AstraZenecand AsDaiichi Sankyo, idatopotamabcderuxtecanvers 'practice-changing' bladder cancer winHRHER2-low or negative breast cancerHER2-lowGilead SciencesTROP2Trodelvy
MeaSeagen, theAstellas watched EV-302 trial has yielded a win for the combinatiobladder cancerd Astellas’ Padcev and Merck’s Keytruda. The combo topped chemotherapy on both overall survival and progression-free survival in previously untreated metastatic bladder cancer. The positive trial could serve to convert the combo’s accelerated approval in platinum-ineligible patients and expand it into the platinum-eligible group.
3. AbbVie axes I-Mab pact to exEV-302t-thinning race for CD47 spaceMerckKeytrudametastatic bladder cancer
AbbAbbVies officially abandoned I-Mab’s anti-CD47 antibodCD47mzoparlimab more than a year after nixing a pair of clinical trials in blood cancers. The deal was originally worth nearly $2 billion, with $180 million upfront. I-Mab is still studying the drug in China, with a phase 3 study ongoing in myelodysplastic syndrome.
AbbVieeda snaps $580M for shot aI-Mabk 6anti-CD47 antibodyPlemzoparlimabrgetblood cancersI-Mabmyelodysplastic syndrome
Takeda has in-licensed the PIKFYVE-targeted amAcuraStem lateral sclerosis pipeline at AcuraStem in a deal potentially worth $580 million. The package includes a preclinical antisense oligonucleotide coded AS-202. AcuraStem suggests targeting the PIKFYVE kinase may also be relevant for treating other diseases such as frontotemporal dementia.
Takedack and Eisai's Keytruda-Lenvima combo amyotrophic lateral sclerosis time in non-AcuraSteml lung cancerAS-202AcuraStemPIKFYVE kinasefrontotemporal dementia
MerMerckd EisEisaiLenvima-Keytruda combo has failed two more trials. Adding Lenvimnon-small cell lung cancerdn’t move the needle for patients with first-line nonsquamous non-small cell lung cancer (NSCLC) in the LEAP-006 trial. In the LEAP-008 trial, the Lenvima-Keytruda regimen couldn’t beat chemo in NSCLC patients who progressed on chemo and anti-PD-1/L1 treatment.
Junshi BiosciencFDA China-made PPD-1 drugPD-1inhibitNeulastaalimab has hit another FDA hurdle. After a preapproval inspection, the FDA flagged a problem at a clinical trial site in China for toripalimab’s application in nasopharyngeal carcinoma. Junshi’s U.S. partner Coherus BioSciences said the single observation is “readily addressable” and that the pair still expects an approval by year-end.
Junshi Biosciencesreject AstraZPD-1a, Daiichi’toripalimabn HER2-low breastFDAncerFDAtoripalimabnasopharyngeal carcinomaJunshiCoherus BioSciences
Enhertu’s efficacy in HERAstraZenecat DaiichiisnEnhertuh itHER2-low breast cancerHER2-lowfor coverage in England, the National Institute for Health and Care Excellence (NICE) ruled in draft guidance. While recognizing the AstraZeneca and Daiichi Sankyo drug is a “potentially significant development” for patients, NICE and the drugmakers clashed on the economic model.
Enhertumark solves itsHER2-low breast cancerHER2-low-long' debt problem with $681M sale of API unit to NirmaNational Institute for Health and Care Excellence (NICE)AstraZenecaDaiichi Sankyo
GleGlenmark selling 75% of its active pharmaceutical ingredient business to Nirma limited for RS 5,651 crore ($681 million). The deal will cover Glenmark’s debt of about RS 4,600 crore, which was described by a local news outlet as a “decade-long troubled affair.” The API unit represents a relatively high profit margin driver within Glenmark.
9. J&J inks 'first of its kind' pact with Singapore government to boost regional life sciences innovation
10.J&Jrides to spin off its CDMO and softgel businesses into single group with 1,200 employees
11. WuXi debuts first vaccine CDMO site in China, where it plans to employ more than 500
12. Eisai wins Japan nod for Alzheimer’s drug Leqembi as Lilly files donanemab (tracker)
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