Fierce Pharma Asia—Enhertu's encore; Akeso's showstopper; GenScript and Legend's US scrutiny

AstraZeneca and Daiichi Sankyo are looking at moving their antibody-drug conjugate Enhertu into another new breast cancer patient class. Ahead of the American Society of Clinical Oncology annual meeting, a cancer antibody from Akeso and Summit Therapeutics stole the show. More Chinese biopharma players are coming under scrutiny from U.S. lawmakers. Plus more.

1. ASCO: AstraZeneca, Daiichi's Enhertu looks to make history again in HER2-ultralow breast cancer

After AstraZeneca and Daiichi Sankyo's Enhertu pioneered the HER2-low category in breast cancer treatment, the partners ignited discussion around the "HER2-ultralow" treatment category at this year's American Society of Clinical Oncology meeting. In a subgroup analysis of the DESTINY-Breast06 trial, Enhertu cut the risk of disease progression or death by 22% versus chemo in certain "HER2-ultralow" patients. The number didn't bear statistical significance. Company executives expressed excitement about the results while experts raised questions about identifying the right patients. 

2. Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think?

On the eve of the American Society of Clinical Oncology's (ASCO's) annual meeting, Akeso and Summit Therapeutics' ivonescimab essentially stole the show with data demonstrating the partners' medicine beat Merck & Co.'s Keytruda in a head-to-head phase 3 trial in lung cancer on the endpoint of progression-free survival. In an interview with Fierce Pharma, Merck's chief medical officer Eliav Barr, M.D., said that overall survival results will remain key as the story plays out. Still, the results elicited a strong response at the ASCO conference.

3. Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech's ties to China

As a U.S. biosecurity crackdown rolls on, two House lawmakers requested FBI director Christopher Wray and U.S. director of national intelligence Avril Haines provide a briefing on the CDMO GenScript and several of its subsidiaries, including the cell therapy specialist Legend Biotech. The lawmakers didn't allege any illicit behavior, but they said the companies' actions "underscore the need for vigilance in safeguarding U.S. competitiveness." 

4. ASCO: AstraZeneca, AbelZeta’s solid tumor CAR-T shows promise in early trial (Release) 

Sino-American biotech AbelZeta, along with multinational AstraZeneca, had their own update to share at the American Society of Clinical Oncology event. In a small study in patients with heavily pretreated advanced hepatocellular carcinoma, the companies' solid tumor CAR-T drug C-CAR031 delivered promising early results. Among 23 study participants who could be evaluated, 91% experienced reductions in the size of their tumors. The data "provide compelling proof-of-concept to potentially redefine therapeutic paradigms" in hepatocellular carcinoma and certain other cancers, AbelZeta CEO Tony (Bizuo) Liu said in a statement.

5. FDA cracks down on China's Hengrui in scathing manufacturing write-up

After an inspection early this year, the FDA handed China's Jiangsu Hengrui Pharmaceuticals a Form 483 manufacturing reprimand with eight observations. Among the agency's findings, the FDA said the company failed to make production records readily available and that it failed to establish adequate sterilization processes. While the company recently received an FDA rejection on an approval application, the manufacturing findings were not related to that decision, a Hengrui spokesperson said. Even though the inspection happened in January, the FDA just posted the Form 483 document this week.

6. South Korea, Japan, India and others form pharma alliance (Yonhap News Agency)

Several large countries, including South Korea, Japan, India and the U.S., formed an alliance to bolster the global pharmaceutical supply chain, Yonhap News Agency reports. Dubbed the Biopharmaceutical Alliance, the group met this week at the BIO convention in San Diego. The participants, which include government officials and biopharma industry representatives, pledged to work together on policies and regulations to advance their effort, the news service reports.

Other News of Note: 

7. Otsuka mauled by ad body for 'unacceptable' transparency failing

8. Lotte Biologics, Merck KGaA ink partnership deal for biopharma production

9. Otsuka, Lundbeck run CGI Abilify ad in promotional push for long-acting bipolar drug

10. Sun Pharma brightens up Ilumya promos with psoriasis campaign encouraging self-love