Weekly Update of Drug News-14/1/2025

By Caleb, staff writer Updated on 2025-01-14 12:55:08 0 0

By Caleb, staff writer

Updated on 2025-01-14 12:55:08 0 0

1. Combination of sasanlimab with BCG improved event-free survival (EFS) in bladder cancer

On 10 January 2025, Pfizer announced positive results from the Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody combining with Bacillus Calmette-Guérin (BCG) as induction therapy for patients with BCG-naïve, high-risk non-muscle invasive bladder cancer. Bacillus Calmette-Guerin (BCG) is a liquid immunotherapy vaccine that treats non-muscle invasive bladder cancer by stimulating the immune system to attack cancer cells in the bladder. The mentioned study met its primary endpoint of EFS showing improvement with sasanlimab in combination with BCG as compared to BCG alone. Moreover, sasanlimab continues to be investigated with different therapeutic combinations to target solid cancers.

Link: https://www.pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-bcg-improves-event-free

2. Nipocalimab was granted Priority Review designation from U.S. FDA

On 9 January 2025, Johnson & Johnson announced that nipocalimab received Priority Review designation from the U.S. FDA for the treatment of antibody-positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG). The decision is based on Phase 3 Vivacity-MG3 study results and will shorten the review period. Generalised myasthenia gravis (gMG) is a rare, chronic autoimmune disease that causes muscle weakness and affects the communication between nerves and muscles. Nipocalimab blocks FcRn to reduce the levels of circulating IgG antibodies potentially without impacting other immune functions. In the trial, nipocalimab plus standard of care (SOC) demonstrated a significantly greater reduction in Myasthenia Gravis – Activities of Daily Living response which reflects symptom severity compared with placebo plus SOC.

Link: https://www.jnj.com/media-center/press-releases/nipocalimab-granted-u-s-fda-priority-review-for-the-treatment-of-generalized-myasthenia-gravis-gmg

3. Elinzanetant successfully managed vasomotor symptoms in cancer patients post endocrine therapy

On 9 January 2025, Bayer announced positive results from the Phase III OASIS 4 study investigating elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms (also known as hot flashes) caused by adjuvant endocrine therapy in women with breast cancer or high risk of developing breast cancer. The study met its primary endpoint and secondary endpoints by reducing the frequency and severity of moderate to severe vasomotor symptoms compared to placebo. Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist modulating the KNDY neurons in the brain to manage hyperactivation of the thermoregulatory pathway, reducing VMS frequency and severity.

Link: https://www.bayer.com/media/en-us/elinzanetant-meets-all-primary-and-secondary-endpoints-in-phase-iii-study-oasis-4-for-treatment-of-moderate-to-severe-vasomotor-symptoms-caused-by-breast-cancer-treatments/

4. Subcutaneous Sarclisa showed non-inferiority to the intravenous dosage form

On 9 January 2025, Sanofi announced the results from the RAKLIA phase 3 study evaluating the new fixed dosage subcutaneous Sarclisa in combination with pomalidomide and dexamethasone (Pd). Sarclisa is an anti-CD38 antibody to treat multiple myeloma, a rare bone marrow cancer. The study met its co-primary endpoints by non-inferior objective response rate (ORR) and observed concentration before dosing (C_trough) at a steady state compared to intravenous administration. Meanwhile, key secondary endpoints, including very good partial response (VGPR), the incidence rate of infusion reactions and C trough at cycle 2 were also achieved.

Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-01-09-06-00-00-3006798

5. Drug/Therapy received approval from the National Medical Products Administration (NMPA) of China

Company	Drug/Therapy	Target	Type	Indication
Merck	GARDASIL® (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant)	/	Vaccine	Expanded use in adult males aged 9-26 years to help prevent certain HPV-related cancers and diseases.
Sanofi	Sarclisa (Anti-CD38 antibody) in combination with pomalidomide and dexamethasone (Pd)	CD38	Combination	Adult patients with multiple myeloma (MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
Astellas	PADCEV^TM (enfortumab vedotin) in combination with KEYTRUDA^® (pembrolizumab)	Nectin-4, PD-1	Combination	Adult patients with locally advanced or metastatic urothelial cancer (la/mUC).
Astellas	VYLOY^TM (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy	Claudin 18.2 (CLDN18.2)	Combination	Adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive