The phase III ENDURANCE trial found that two years of lenalidomide maintenance therapy provides the same overall survival benefit as indefinite treatment until progression for patients with standard-risk multiple myeloma. After nearly seven years of follow-up, overall survival rates were 68.6 percent in the indefinite treatment group versus 69.0 percent in the two-year limited duration group. Indefinite therapy was associated with higher rates of side effects including fatigue, anemia, and diarrhea, and a slightly higher incidence of second primary cancers over five years. The trial enrolled 516 patients who had completed initial treatment but were not candidates for upfront stem cell transplantation. Lead author Dr. Shaji Kumar and senior author Dr. S. Vincent Rajkumar, both of the ECOG-ACRIN Myeloma Committee, said the results support a fixed-duration approach as a new standard of care for standard-risk patients.
Akeso Wins China Phase I Clearance for AK158D1 Bispecific ADC
Akeso has secured Phase I clinical trial clearance in China for AK158D1, a bispecific antibody drug conjugate targeting EGFR and TROP2 in advanced solid tumors. The clearance puts fresh attention on the company's pipeline as it pushes deeper into IO2.0 and ADC2.0. Akeso's shares recently traded at HK$90.5, up 3.37% over 90 days but down 20.12% year to date, against a consensus analyst price target of HK$158.28, with the most bullish target at HK$226.04 and the most bearish at HK$125.08. The company remains exposed to execution setbacks given its reliance on a handful of key drugs and a current net loss of CN¥967.2 million.
Merck's KEYTRUDA Plus Padcev Wins CHMP Backing for EU Bladder Cancer
Merck received a positive opinion from the European Medicines Agency's CHMP for KEYTRUDA plus Padcev in muscle-invasive bladder cancer. The CHMP backed the combination as perioperative therapy for adults with resectable muscle-invasive bladder cancer in the European Union. If endorsed by the European Commission, the regimen would be the first PD-1 inhibitor plus antibody-drug conjugate option for this setting in Europe. The addressable group in Europe is relatively concentrated but clinically high need, with bladder cancer cases estimated at about 224,700 in 2022, roughly 25% of them classified as muscle invasive. The key near-term marker is the European Commission ruling expected by the fourth quarter of 2026, since the CHMP only issues recommendations.
FDA Grants Full Approval to Lilly's Inluriyo Plus Verzenio for ESR1-Mutated Breast Cancer
Eli Lilly and Company announced that the U.S. Food and Drug Administration has granted full approval to Inluriyo, or imlunestrant, in combination with Verzenio, or abemaciclib, for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The decision rests on the Phase 3 EMBER-3 trial, in which the combination doubled median progression-free survival versus Inluriyo alone, at 11.1 months versus 5.5 months, with a hazard ratio of 0.53 and a 95% confidence interval of 0.35 to 0.80, among the 159 patients with ESR1-mutated metastatic breast cancer. In that trial, 92 patients received Inluriyo alone and 67 received the combination after an aromatase inhibitor, with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. The approval marks the second FDA clearance for Inluriyo in less than a year, following its September 2025 monotherapy approval for the same ER-positive, HER2-negative, ESR1-mutated metastatic population. Inluriyo is also being studied in the Phase 3 EMBER-4 trial in the adjuvant setting for ER-positive, HER2-negative early-stage breast cancer, the largest adjuvant oral SERD trial with more than 8,000 patients enrolled across 650-plus sites in more than 30 countries, with initial results anticipated in 2027. The combination is now available in the United States.