AMERICAN SOCIETY OF CLINICAL ONCOLOGY

The CBCF ALC panel 'The Road to Health Equity' discussed mistrust in clinical trials among Black communities, citing historical abuses like Tuskegee and Henrietta Lacks. Inclusivity in trials is crucial for medical equity, yet Black Americans are underrepresented. Initiatives like EQBMED aim to increase diversity and trust in clinical research.

FDA approves pembrolizumab plus chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial findings showing significant OS improvement.

FDA approves Kisqali (ribociclib) for HR+/HER2- stage II and III early breast cancer, reducing recurrence risk by 25% with endocrine therapy. NATALEE trial results show consistent benefits and well-tolerated safety profile across subgroups, including node-negative patients. Kisqali is under regulatory review worldwide.

CEACAM5 drugs market to grow significantly due to rising cancer diagnoses and clinical trials; no CEACAM5 drugs currently approved. Key companies developing CEACAM5 drugs include Merck KGaA, Sanofi, and Roche. Emerging therapies like SGM-101 and M9140 show promise in clinical trials.

The phase 3 CONTACT-02 trial showed cabozantinib and atezolizumab combination favored over a second novel hormonal therapy in metastatic castration-resistant prostate cancer, though OS trend did not achieve statistical significance. Median OS was 14.8 months vs 15.0 months, with subgroup analysis indicating survival advantage for liver and bone metastasis patients. Safety profile consistent with other trials. Exelixis plans FDA submission, while Ipsen opts not to pursue regulatory submissions outside US and Japan.

FDA approves Kisqali (ribociclib) with aromatase inhibitor for HR+/HER2- stage II and III EBC at high risk of recurrence, based on NATALEE trial showing 25% reduced risk of recurrence vs. endocrine therapy alone, with consistent benefit across subgroups.

Diaceutics reports 24% revenue growth to £12.3m, with 55% of revenues recurring and a record order book of £27.9m. The company launched PMx, securing its first commercial contract, and is on track for profitability and cash flow generation from 2025.

Japan's MHLW accepts GSK's NDA for Blenrep plus BorDex or PomDex for relapsed/refractory multiple myeloma, based on DREAMM-7 and DREAMM-8 trials. Blenrep shows potential to redefine treatment landscape.

FDA approves Kisqali, a ribociclib-based treatment, in combination with an aromatase inhibitor for adjuvant therapy of HR+/HER2- stage II and III early breast cancer patients at high risk of recurrence, including those with node-negative disease. The approval is supported by the Phase III NATALEE trial results, which demonstrated a 25.1% reduction in disease recurrence risk and a well-tolerated safety profile.

Diaceutics reports 24% revenue growth, 28% on constant currency, with a record order book of £27.9m. 55% of revenues are recurring, aiming for 70% by 2025. The company added 26% more customer therapeutic brands and secured three new enterprise-wide engagements. PMx was launched, securing its first commercial contract. A two-year investment phase nears completion, with profitability and cash flow generation forecast from 2025. The balance sheet remains strong with £16.7m in cash.