Gilead Reports Positive Phase 3 Results for HIV Therapy BIC/LEN; FDA Approves J&J's Akeega for BRCA2-Mutated Prostate Cancer

Gilead's HIV Therapy Reports Positive Results in Another Phase 3 Trial

Gilead Sciences announced today that the ARTISTRY-2 clinicalPhase 3The trial achieved positive primary outcomes. This randomized, double-blind trial evaluated the treatment outcomes of switching virologically suppressed adults living with HIV from the current regimen Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). The analysis showed,BIC/LEN met the statistical non-inferiority criteria in efficacy compared to Biktarvy.

In the ARTISTRY-2 study, the primary efficacy endpoint was the proportion of participants with plasma HIV-1 RNA levels ≥50 copies/mL at week 48. The analysis showed that the once-daily single-tablet regimen BIC/LEN met the non-inferiority criteria compared to Biktarvy for the primary endpoint. Additionally, this novel BIC/LEN combination regimen was generally well-tolerated, with no significant or new safety issues identified.Gilead Plans to Submit Phase 3 Results of ARTISTRY Series Trials (Including ARTISTRY-1 and ARTISTRY-2) to Global Regulatory Authorities.

FDA Approves Johnson & Johnson's Small Molecule Combination for Cancer Again

Johnson & Johnson recently announced that the U.S. FDA has approved its Akeega (niraparib and abiraterone acetate dual mechanism combination tablet [DAT]) in combination with prednisone for the treatment of patients carryingBRCA2Patients with mutated metastatic castration-sensitive prostate cancer (mCSPC).Niraparib is a highly selective PARP oral inhibitor; Abiraterone acetate is an orally administered androgen biosynthesis inhibitor.

This approval is mainly based on the positive results of the AMPLITUDE study. This is a randomized, double-blind, placebo-controlled international multicenter Phase 3 clinical study. In carriersBRCA2In patients with mutated mCSPC, Akeega combined with prednisone and androgen deprivation therapy (ADT), compared to placebo/abiraterone acetate combined with prednisone and ADT,The risk of radiological disease progression or death was significantly reduced by 54% (HR=0.46, 95% CI: 0.32–0.66). Additionally, this combination regimen delayed the time to symptom progression by 59% (HR=0.41, 95% CI: 0.29–0.65).

Positive Phase 3 Results for Small Molecule, Regulatory Submission Planned for Next Year

Immunome Announces Positive Topline Results from Global Pivotal Phase 3 RINGSIDE Trial Evaluating Varegacestat, an Investigational Once-Daily Oral γ-Secretase Inhibitor (GSI), for the Treatment of Patients with Progressive Nodular Fibroma

Analysis shows that varegacestat achieved the primary endpoint, significantly improving patients' progression-free survival.Compared with placebo, the therapy reduced the risk of disease progression or death by 84% (HR=0.16, 95% CI: 0.071–0.375; p<0.0001)., with statistical significance and clinical meaningfulness. In addition, the trial met all key secondary endpoints. The objective response rate (ORR) confirmed by blinded independent central review showed that the varegacestat group was 56%, significantly higher than the 9% in the placebo group (p<0.0001). Exploratory analysis further indicated,Varegacestat achieved a median best change in tumor volume of -83%, compared to +11% in the placebo group.The study also showed that varegacestat was generally well-tolerated with controllable safety.Immunome Plans to Submit New Drug Application (NDA) to U.S. FDA in Q2 2026

References:

[1] U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care*. Retrieved December 15, 2025 from https://www.prnewswire.com/news-releases/us-fda-approves-akeega-as-the-first-precision-therapy-for-brca2-mutated-metastatic-castration-sensitive-prostate-cancer-with-54-reduction-in-disease-progression-vs-standard-of-care-302640552.html

[2] Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors. Retrieved December 15, 2025 from https://investors.immunome.com/immunome-announces-positive-topline-results-from-phase-3-ringside-trial-of-varegacestat-in-patients-with-desmoid-tumors/

[3] Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial. Retrieved December 15, 2025 from https://www.businesswire.com/news/home/20251215879862/en/Gileads-Investigational-Single-Tablet-Regimen-of-Bictegravir-and-Lenacapavir-for-HIV-Treatment-Meets-Primary-Endpoint-in-Phase-3-ARTISTRY-2-Trial

Disclaimer: This article is for the purpose of information exchange only. The views expressed in the article do not represent the position of WuXi AppTec, nor does WuXi AppTec support or oppose the views mentioned in the article. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: Individuals are welcome to share this article on their Moments. Unauthorized reproduction by media or organizations in any form to other platforms is prohibited. For reprint authorization, please reply "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain the reprint guidelines.