Merck and Eisai's Keytruda-Lenvima combo failed to outdo Keytruda monotherapy in newly diagnosed lung cancer. Johnson & Johnson and partner Legend Biotech touted lasting multiple myeloma progression benefit for their CAR-T rival to Bristol Myers Squibb's Abecma. Samsung Biologics expanded its contract manufacturing pact with AstraZeneca to include the company's COVID-19 antibody cocktail Evusheld. And more.
1. Merck, Eisai's 007 goes down as Keytruda-Lenvima combo fails in newly diagnosed lung cancer
Merck and Eisai’s attempt to improve upon Keytruda monotherapy with a Lenvima combo has failed in newly diagnosed, PD-L1-positive non-small cell lung cancer. In the phase 3 LEAP-007 trial, adding Lenvima to Keytruda didn’t extend patients’ lives, but instead increased the rate of grade 3 to 5 treatment-related side effects. The pair has two other ongoing phase 3 trials of the Keytruda-Lenvima combo in lung cancer.
After a median follow-up of 22 months, Johnson & Johnson and Legend Biotech’s BCMA CAR-T cell therapy cilta-cel has yet to reach its median progression-free survival (PFS) in the CARTITUDE-1 trial in heavily pretreated multiple myeloma. Legend predicts that the final median PFS will top 23 months, far longer than the median PFS observed in the KarMMa trial of Bristol Myers Squibb’s rival drug Abecma.
3. Samsung Biologics, AstraZeneca expand manufacturing partnership to add COVID and cancer therapies
Samsung Biologics and AstraZeneca are expanding the scope of their long-term biologics manufacturing agreement to include the latter’s long-acting COVID-19 antibody therapy Evusheld (AZD7442). The combo won an FDA emergency use authorization last week for prevention of COVID in immunocompromised individuals.
4. Eli Lilly pens $1.5B biobucks pact with China's Regor for metabolic disease work
Eli Lilly is shelling out $50 million upfront to gain access to Regor Therapeutics’ computation-powered drug discovery platform to develop new drugs for metabolic disorders. Up to $1.5 billion is up for grabs in milestone payments. Lilly gains ex-China rights to drugs coming out of the pact.
5. Fujifilm beefs up US biologics capacity with $300M Texas outlay, corrals 150 new jobs
Fujifilm Diosynth Biotechnologies is investing $300 million to expand its manufacturing facility in College Station, Texas. The expansion will double the CDMO’s advanced therapy and vaccine manufacturing capacity in the U.S., and it’s set to add 150 new jobs by 2024.
6. ASH: Astellas looks for silver linings in failed Xospata combo trial
Astellas’ Xospata failed in a phase 3 trial in newly diagnosed FLT3-mutated acute myeloid leukemia. The addition of the drug to Bristol Myers Squibb’s Vidaza failed to top Vidaza alone at extending patients’ lives. The drug did show better results in fitter patients, or those with a high level of FLT3 mutation.
7. Takeda previews early response data for 'Wave 2' multiple myeloma med in follow-up to Velcade
Takeda’s anti-CD38 drug modakafusp alfa (TAK-573) eradicated signs of tumor in two of 29 heavily pretreated patients with multiple myeloma in a phase 1 study. Six patients had a very good partial response to the immunocytokine therapy at the 1.5 mg/kg strength. The patients went a median of 5.7 months without disease worsening.
8. BeiGene slides in Shanghai after $3.5B STAR market debut (Reuters)
BeiGene’s stock slid 16% on its first day of trading on Shanghai’s STAR market Wednesday. For its third listing, the company offered its shares at large premiums to its listings on the Nasdaq and the Hong Kong Stock Exchange. Chinese biopharma stocks suffered a bloodbath on the day over rumors of possible inclusion for biotechs in a U.S. import blacklist.
9. CanSino taps Aerogen for development, commercial supply of inhaled COVID-19 vaccine hopeful
CanSino Biologics and drug delivery specialist Aerogen have teamed up to develop an inhaled version of CanSino’s recombinant COVID-19 vaccine Convidecia, which is approved in China. Aerogen will offer its vibrating mesh aerosol drug delivery technology. The hope is that an inhaled product would require a considerably smaller volume and therefore stretch capacity.