Fierce Pharma Asia – Merck, Eisai’s Failed Lenvima Study; J&J, Legends CAR-T data; AstraZeneca-Samsung COVID pact – archyde

The Keytruda-Lenvima combination from Merck and Eisai could not outperform Keytruda monotherapy in newly diagnosed lung cancer. Johnson & Johnson and its partner Legend Biotech have touted an enduring benefit in multiple myeloma progression for their CAR-T rival from Bristol Myers Squibbs Abecma. Samsung Biologics has expanded its contract manufacturing pact with AstraZeneca to include the company’s Evusheld COVID-19 antibody cocktail. And more.

1. Merck, Eisais 007 goes under when the Keytruda-Lenvima combination fails in newly diagnosed lung cancer

Merck and Eisai’s attempt to improve Keytruda monotherapy with a Lenvima combination has failed in newly diagnosed PD-L1 positive non-small cell lung cancer. In the Phase 3 LEAP-007 study, the addition of Lenvima to Keytruda did not increase the patient’s life but instead increased the rate of Grade 3 to 5 treatment-related adverse reactions. The couple has two other Phase 3 studies ongoing with the Combination Keytruda-Lenvima in lung cancer.

2. ASH: After 2 years, J & J’s rival BCMA cell therapy from Bristol Myers is still growing

After a median follow-up of 22 months, the BCMA CAR-T cell therapy Cilta-Cel from Johnson & Johnson and Legend Biotech has not yet achieved median progression-free survival (PFS) in the CARTITUDE-1 study in heavily pretreated multiple myeloma. Legend predicts that the final median PFS will exceed 23 months, far longer than the median PFS seen in the KarMMa study with Bristol Myers Squibb’s competing drug Abecma.

3. Samsung Biologics and AstraZeneca expand manufacturing partnership to include COVID and cancer therapies

Samsung Biologics and AstraZeneca are expanding the scope of their long-term biologics manufacturing agreement to include its long-term COVID-19 antibody therapy Evusheld (AZD7442). The combination received FDA emergency approval for the prevention of COVID in immunocompromised people last week.

4. Eli Lilly signs a biobucks pact worth 1.5 billion with China’s Regor

Eli Lilly is spending $ 50 million upfront to gain access to Regor Therapeutics’ computational drug discovery platform to develop new drugs for metabolic disorders. Milestone payments of up to $ 1.5 billion can be won. Lilly acquires ex-China rights to drugs that come from the pact.

5. Fujifilm increases US biologics capacity with spending $ 300 million in Texas, creating 150 new jobs

Fujifilm Diosynth Biotechnologies is investing $ 300 million to expand its College Station, Texas manufacturing facility. The expansion will double CDMO’s advanced therapy and vaccine manufacturing capacity in the United States, and aim to create 150 new jobs by 2024.

6. ASH: Astellas is looking for silver linings in failed Xospata combination study

Astellas’ Xospata failed a phase 3 study in newly diagnosed FLT3-mutated acute myeloid leukemia. The addition of the drug to Bristol Myers Squibb’s Vidaza could not, on its own, outperform Vidaza in extending patients’ lives. The drug showed better results in fitter patients or those with a high FLT3 mutation.

7. Takeda Preview Early Response Data for Multiple Myeloma Wave 2, the successor to Velcade

Takeda’s anti-CD38 drug modakafusp alfa (TAK-573) eliminated the signs of tumors in two of 29 heavily pre-treated patients with multiple myeloma in a Phase 1 study. Six patients showed a very good partial response to immunocytokine therapy with a strength of 1.5 mg / kg. The patients remained without disease worsening for a median of 5.7 months.

8. BeiGene slips in Shanghai after USD 3.5 billion STAR market debut (Reuters)

BeiGene’s stock slipped 16% on the first day of trading in Shanghai’s STAR market on Wednesday. For its third listing, the company offered its shares at high premium to its listings on the Nasdaq and the Hong Kong Stock Exchange. Chinese biopharma stocks suffered a bloodbath that day over rumors that biotech might be blacklisted for US imports.

9. CanSino hopefully uses Aerogen to develop, commercial supply of inhaled COVID-19 vaccine

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 will require a significantly lower volume and therefore stretch.


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