AS-202

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 antibody-drug conjugate in development 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. 1. AstraZeneca, Daiichi hit first goal in pivotal breast cancer ADC trial, teeing up filings to challenge Gilead AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan has beaten chemotherapy at delaying disease progression or 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. 2. Seagen and Astellas' Padcev, in Keytruda combo, delivers 'practice-changing' bladder cancer win Meanwhile, the closely watched EV-302 trial has yielded a win for the combination of Seagen and 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 exit fast-thinning race for CD47 space AbbVie has officially abandoned I-Mab’s anti-CD47 antibody lemzoparlimab 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. 4. Takeda snaps $580M for shot at pick 6 with AcuraStem's PIKFYVE ALS target Takeda has in-licensed the PIKFYVE-targeted amyotrophic 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. 5. Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer Merck and Eisai’s Lenvima-Keytruda combo has failed two more trials. Adding Lenvima to Keytruda and chemo didn’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.   6. Coherus hits FDA hurdles for PD-1 drug, Neulasta biosimilar on-body injector Junshi Biosciences’ China-made PD-1 inhibitor toripalimab 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. 7. NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer Enhertu’s efficacy in HER2-low breast cancer isn’t worth its price for 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. 8. Glenmark solves its 'decade-long' debt problem with $681M sale of API unit to Nirma Glenmark is 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. Other News of Note 9. J&J inks 'first of its kind' pact with Singapore government to boost regional life sciences innovation 10. Strides 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)