Johnson & Johnson and Legend Biotech's Carvykti showed a massive cancer progression benefit in leaked multiple myeloma trial data. The pair also recruited Novartis to help ramp up supply of the CAR-T therapy. Meanwhile, Novartis and BeiGene returned with a broader patient survival win for tislelizumab in stomach cancer. Plus more.
J&J and Legend’s Carvykti data in earlier multiple myeloma were leaked online. An abstract showed the CAR-T therapy cut the risk of progression or death by a spectacular 74% compared with standard of care when used in patients who had tried one to three lines of therapy. The result exceeded some of the high expectations held by industry watchers.
2. J&J, Legend tap Novartis to help make CAR-T drug Carvykti as they work through supply constraints
While Carvykti’s stellar data will likely spur demand, manufacturing remains a bottleneck. To help ramp up supply, J&J and Legend have tapped Novartis to make Carvykti for clinical trials outside China in a three-year contract. But the tech transfer and an additional FDA approval will take some time, Legend CEO Ying Huang, Ph.D., said.
3. BeiGene, Novartis' tislelizumab stages comeback with broader stomach cancer trial win
BeiGene and Novartis’ tislelizumab expanded its previously limited win in stomach cancer. The PD-1 inhibitor’s life extension benefit in newly diagnosed patients now covers all patients with or without PD-L1 expression in their tumors. The recent victory puts tislelizumab on a collision course with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo.
4. FDA advisers back Lundbeck and Otsuka's Rexulti in Alzheimer's disease agitation
After a seemingly positive FDA internal review, Lundbeck and Otsuka’s application for Rexulti in Alzheimer’s-disease-related agitation got a thumbs-up from the agency’s external advisers. Most experts during an advisory committee meeting said the drug has convincing data in what would be the first nod for the specific condition with high unmet need.
5. Teva wraps up sale of India manufacturing facility to Marksans
Teva has sold a 47,597-square-meter facility in Goa, India, to Marksans Pharma for an undisclosed price. The deal allows Marksans to double its capacity in India from a current level of 8 billion units per year. The added capacity will be shared among tablets, capsules, ointments, liquids and creams.
6. Minghui's phase 2 win for JAK inhibitor cream sets up potential Opzelura competitor
China’s Minghui Pharma said its topical pan-JAK inhibitor hit its goal in a phase 2 trial in mild to moderate atopic dermatitis. The FDA has already signed off on a phase 3 trial of the drug, coded MH004. If successful, the drug would go up against Incyte’s JAK cream Opzelura.
7. Eisai helps build a head and neck cancer community through interactive stories
Eisai has teamed with several head and neck cancer groups to create a new campaign called “Made of More” to support the community. The campaign’s main component, MadeOfMore.com, features interactive artwork that tells the stories of real people affected by the cancer type.
8. China’s Hasten rakes in $315M to fund future in-licensing deals (release)
China’s Hasten Biopharmaceutic closed a $315 million financing round co-led by CBC Group and Abu Dhabi's sovereign wealth fund, Mubadala Investment Company. The money will be used to fund future in-licensing deals. The company made a name back in 2020 when it paid Takeda $322 million for rights to five drugs in certain geographies.