Fierce Pharma Asia—Enhertu's historic nod; Hutchmed's trial wins; BeiGene, Novartis' liver cancer readout

AstraZeneca and Daiichi Sankyo's Enhertu received a groundbreaking HER2-low breast cancer approval four months ahead of schedule. Hutchmed reported encouraging midstage results for its AstraZeneca-partnered c-Met inhibitor savolitinib as well as positive registrational data for colorectal cancer therapy fruquintinib. Novartis and BeiGene's PD-1 inhibitor tislelizumab hit a phase 3 goal in newly diagnosed liver cancer. And more.

1. In historic FDA nod, AstraZeneca, Daiichi’s Enhertu snags ultrafast approval in broad HER2-low breast cancer use

Less than two weeks after AstraZeneca and Daiichi Sankyo said their application for Enhertu in HER2-low breast cancer was accepted for priority review, the FDA doled out the landmark approval. The go-ahead opens up HER2-low, which accounts for about 50% of all breast cancer diagnoses in the U.S., as a new treatment category. Enhertu is allowed in patients after one prior chemo in the metastatic setting or in patients who relapsed quickly after postsurgery adjuvant chemo.

2. AstraZeneca-Daiichi Sankyo's ADC barrels forward as Keytruda combo data make case for lung cancer use

AZ and Daiichi’s second antibody-drug conjugate, the TROP2-directed datopotamab deruxtecan, reported a 40% tumor response rate when used alongside Merck’s Keytruda, with or without platinum chemo, in a phase 1b non-small cell lung cancer trial. In a small group of newly diagnosed patients, the response rate was 62% for the doublet and 50% for the triplet.

3. After FDA snub, Hutchmed touts promising data for two other oncology meds

Hutchmed delivered two positive trial readouts. Adding fruquintinib to standard of care further prolonged the lives of patients with previously treated colorectal cancer. The drug has been approved in China under the brand name Elunate, and Chi-Med said it will file for approvals in the U.S., Europe and Japan. Meanwhile, a pairing of AstraZeneca-partnered savolitinib and AZ’s Tagrisso shrunk tumors in 32% of patients who had developed resistance to Tagrisso in a phase 2 lung cancer study.

4. Novartis, BeiGene's PD-1 hits goal in first-line liver cancer. Should Roche worry about Tecentriq?

BeiGene said its Novartis-partnered tislelizumab matched up to Bayer’s Nexavar at extending lives in newly diagnosed unresectable liver cancer. BeiGene said the RATIONALE 301 trial is “intended to support global registrations,” but whether the company will file for tislelizumab monotherapy was unclear. Within the PD-1/L1 class, Roche’s Tecentriq, used in tandem with Avastin, already boasts an FDA approval in this setting.

5. Bayer's Xarelto squeeze rolls on as cancer newcomer Nubeqa gains steam

Bayer’s Xarelto continues to feel the impact from China’s volume-based procurement price-cutting scheme. In the second quarter, Bayer reported a 6% year-over-year sales decline for Xarelto outside the U.S. The Chinese government-led generics purchase program weighed on price and volumes, Bayer said. 

6. Zai Lab to shop around CD47 after deciding to ‘deprioritize’ internal development

After AbbVie capped development of a CD47 program from China’s I-Mab, Zai Lab has decided to deprioritize its own CD47 antibody ZL-1201. Despite having a recommended phase 2 dose, Zai cited “competitive landscape” for the decision.

7. Pursuing AbbVie and J&J, Innovent hits primary endpoint in phase 2 psoriasis trial

Innovent Biologics said its IL-23 antibody, picankibart, outperformed placebo at reducing psoriasis area and severity. Other FDA-approved products in the drug class include AbbVie’s Skyrizi, Johnson & Johnson’s Tremfya and Sun Pharma’s Ilumya, but Innovent sees promise in its candidate’s extended half-life, which allows for less frequent dosing.

8. Fierce Biotech Fundraising Tracker: Insilico adds $35M to series D, Vector launches with $30M

Insilico Medicine has raised an additional $35 million for a series D round, bringing the total to $95 million. The money will support the AI drug discovery specialist’s lead asset, which is being researched in idiopathic pulmonary fibrosis. It will also allow the company to expand its platform into other areas such as sustainable chemistry, green energy and agriculture.