Clinical Trial News

Bicara Therapeutics raised $315 million in IPO to fund a pivotal study for its head and neck cancer therapy, ficerafusp alfa, which targets EGFR and TGF-beta signaling. The drug, combined with Keytruda, showed a 54% overall response rate in advanced HNSCC patients, with 64% in HPV-negative cases. A Phase 2/3 trial is planned for 2025.

Japan's Ministry of Health, Labor and Welfare approves KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine for adults 18 and older, targeting the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's partner in Japan, will distribute the vaccine in time for the October COVID-19 vaccination campaign.

Final analysis of LITESPARK-005 showed belzutifan maintained PFS and ORR benefits over everolimus in advanced clear cell RCC, with durable responses lasting over 2 years, though no OS improvement. Belzutifan, an oral HIF-2a inhibitor, led to a higher ORR (22.7%) vs everolimus (3.5%) and longer median DOR (19.3 months vs 13.7 months). Despite longer treatment duration, belzutifan exhibited comparable or reduced toxicities. No new safety signals were observed.

Targeted therapies improve outcomes in EGFR-mutant NSCLC, with studies like MARIPOSA showing amivantamab plus lazertinib reduces resistance mechanisms. MARIPOSA-2 highlights amivantamab plus chemotherapy's survival benefits post-osimertinib. Zipalertinib shows promise for EGFR exon 20 insertion-mutated NSCLC, indicating a move towards personalised, precision-guided treatment approaches.

Bayer will present new prostate cancer data, including a Phase III ARANOTE trial analysis of NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC), at the ESMO Congress 2024 in Barcelona.

Dr. Shirish M. Gadgeel discusses MARIPOSA-2 data at ESMO 2024, highlighting improvements in targeted therapies, immunotherapy combinations, and antibody-drug conjugates, emphasizing the ongoing trend of individualized cancer treatment for better efficacy and quality-of-life.

Adjuvant durvalumab did not improve disease-free survival in EGFR-/ALK-negative NSCLC patients, regardless of PD-L1 expression levels, according to the phase 3 BR.31 trial results presented at the 2024 ESMO Congress.

Roche's subcutaneous Tecentriq approved for cancer treatment; Gilead's twice-yearly HIV shot reduces infection risk by 96%; Biogen appoints Lloyd Minor and Menelas Pangalos as independent directors; Sanofi secures rights to a rare cancer radiopharmaceutical; Eli Lilly to expand Irish manufacturing for Alzheimer's drug Kisunla.

Masofaniten + enzalutamide well-tolerated, showing durable PSA reductions in mCRPC patients. Phase 2 expansion ongoing with 600 mg BID masofaniten + 160 mg QD enzalutamide. 88% achieved PSA90, 69% in <90 days, 63% PSA <0.2ng/mL. Median time to PSA/radiographic progression not yet reached after 15.2 months.

Beyond Celiac celebrates National Celiac Awareness Day on Sept. 13, highlighting progress in research and the ongoing need for a cure. The organization aims to find a cure by 2030 for the 3.2 million diagnosed with celiac disease, currently treated only by a gluten-free diet. Beyond Celiac Investments (BCI) aims to accelerate treatments and a cure, raising $1.5 million towards a $2 million goal. The Beyond Celiac Coalition met with the FDA to discuss patient-centric clinical trials, emphasizing the need for less invasive procedures.