Abbisko Therapeutics Co. Ltd. and AstraZeneca Plc have entered a strategic collaboration to jointly develop a novel combination therapy for patients with EGFR-mutated and PD-L1 positive non-small cell lung cancer (NSCLC). The partnership aims to address a persistent treatment gap for patients who typically derive less benefit from standard EGFR-TKI treatments when their tumors express high levels of PD-L1.

China Clears Phase 1/2 Combination Study

The National Medical Products Administration (NMPA) cleared the investigational new drug (IND) application for the study on May 20, 2026. The multicenter, open-label Phase 1/2 trial will assess the safety and efficacy of combining Abbisko's oral PD-L1 inhibitor, lumipodlin (ABSK043), with AstraZeneca's EGFR-targeted therapy, TAGRISSO (osimertinib).

Abbisko will lead the Phase 2 study, while both companies will share responsibilities for conducting the clinical trial. Lumipodlin is being developed as a potentially first-in-class oral small-molecule PD-L1 inhibitor.

AstraZeneca Expands Collaboration Pipeline

Separately, Hong Kong-based CSPC Pharmaceutical Group announced a collaboration, option, and license agreement with AstraZeneca to develop novel small nucleic acid drug candidates. CSPC will receive a $30 million upfront payment and could earn up to $540 million in development milestones, up to $1.2 billion in sales milestones, and single-digit sales-based royalties.

Under the agreement, the companies will jointly discover and develop preclinical candidates for two renal disease targets. AstraZeneca will have the option to secure exclusive global or ex-China rights to develop, manufacture, and commercialize each program. CSPC will retain development, manufacturing, and commercialization rights in China for one preclinical candidate.

In June, Abbisko Therapeutics announced a new strategic research collaboration and license agreement with Eli Lilly and Co. aimed at discovering and developing innovative medicines across multiple disease targets.

AstraZeneca Plc reported positive late-stage data for investigational therapy efzimfotase alfa in children with hypophosphatasia (HPP), while separately securing European Union approval for cancer drug Enhertu in a broad group of HER2-positive solid tumors. These developments mark significant milestones across the company's rare disease and oncology portfolios. The Enhertu approval triggers a $25 million milestone payment to partner Daiichi Sankyo.

Efzimfotase Alfa Meets Primary And Secondary Endpoints

Data from the Phase 3 MULBERRY trial showed efzimfotase alfa, also known as ALXN1850, significantly improved bone health in children aged 2 to under 12 years with HPP who had not previously received Strensiq (asfotase alfa). Patients treated with efzimfotase alfa achieved a median Radiographic Global Impression of Change (RGI-C) score of 1.67 at week 25, compared with 0 in the placebo group, representing a statistically significant difference (p=0.0003).

The trial also met its key secondary endpoint, with patients receiving the therapy showing significant improvement in Rickets Severity Score versus placebo. Beyond bone health, efzimfotase alfa demonstrated improvements in measures of physical function and quality of life, including gains in Pediatric Outcomes Data Collection Instrument scores and clinically meaningful improvement in the Six-Minute Walk Test.

Safety Profile And Injection-Site Reactions

In the Phase 3 CHESTNUT trial, children who switched from Strensiq to efzimfotase alfa experienced treatment-emergent adverse events at rates comparable to those who remained on Strensiq, while maintaining bone health outcomes through week 25. AstraZeneca said efzimfotase alfa was generally well-tolerated across all three Phase 3 studies.

A pooled analysis from the MULBERRY and HICKORY studies showed the annualized injection-site reaction rate was five times lower with efzimfotase alfa than that observed with Strensiq in registrational studies. Patients treated with efzimfotase alfa also recorded a median of 98.8% injection-site-reaction-free days during treatment.

Enhertu Receives EU Tumor-Agnostic Approval

Separately, AstraZeneca and Daiichi Sankyo announced that Enhertu (trastuzumab deruxtecan) received approval from the European Commission as a monotherapy for adults with unresectable or metastatic HER2-positive solid tumors who have previously received treatment and lack satisfactory treatment options. The approval was based on data from the Phase 2 DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 trials, which demonstrated confirmed objective response rates ranging from 46.9% to 52.9% across multiple tumor types.