1. Tecentriq plus lurbinectedin significantly improves survival in first-line maintenance for ES-SCLC

On 3 June 2025, Roche announced positive results from a Phase III study investigating Tecentriq® (atezolizumab, anti-PD-L1) in combination with lurbinectedin (Zepzelca®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC). The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. 

In the study, patients were first given four cycles of Tecentriq combined with chemotherapy before being randomised into maintenance treatment with or without lurbinectedin. The median overall survival for the Tecentriq with lurbinectedin group was 13.2 months versus 10.6 months for Tecentriq alone. Median progression-free survival was 5.4 months versus 2.1 months, respectively.

Link: https://www.roche.com/media/releases/med-cor-2025-06-03

2. Niraparib plus AAP significantly reduces progression risk in mCSPC with genetic alterations

On 3 June 2025, J&J announced results from AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with genetic alterations. Niraparib is a PARP inhibitor, and AAP blocks the androgen receptor pathway.

The phase 3 study met its primary endpoint of radiographic progression-free survival (rPFS). Until now, the median rPFS has not been reached compared to 26 months in patients treated with the placebo plus AAP,  reducing the risk of radiographic progression or death by 48%. For the subgroup analysis, niraparib combination reduced the risk of symptomatic progression by 56% in patients with BRCA alterations and 50% in patients with HRR alterations.

Link: https://www.jnj.com/media-center/press-releases/johnson-johnson-leads-with-first-parp-inhibitor-combo-to-improve-efficacy-in-patients-with-hrr-altered-mcspc

3. JNJ-5322 showed high efficacy in multiple myeloma patients

On 3 June 2025, J&J announced results for JNJ-79635322, a novel investigational trispecific antibody to treat patients with relapsed or refractory multiple myeloma. Unlike bispecific antibodies, JNJ-5322 is a single molecule binding to three distinct targets, BCMA, GPRC5D and CD3. In the trial, 126 patients received JNJ-5322 with a median follow-up of 8.2 months. Among the 36 patients who received the recommended phase 2 dose, the overall response rate (ORR) was 86.1%. In 27 patients who were naive to BCMA and GPRC5D-directed therapies, the ORR was 100% at the phase 2 dose. 

Link: https://www.jnj.com/media-center/press-releases/early-results-from-johnson-johnsons-trispecific-antibody-show-promising-response-in-heavily-pretreated-multiple-myeloma-patients

4. Dupixent led to 76% EASI-75 response and reduced hyperpigmentation in atopic dermatitis: On 8 June 2025, Sanofi announced a phase 4 study assessing Dupixent (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis. In the trial, 120 patients were treated with Dupixent every two weeks. 76% of patients achieved more than 75% improvement in overall disease severity (EASI-75), the primary endpoint. Meanwhile, 53% achieved clinically meaningful improvement in itch. There was also a 53% reduction in post-inflammatory hyperpigmentation, dropping from 5.1 points to 2.4 points.

Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-07-22-30-00-3095548

5. Enhertu plus pertuzumab reduced disease progression risk in first-line HER2-positive metastatic breast cancer

On 2 June 2025, AstraZeneca and Daiichi Sankyo showed positive results from the DESTINY-Breast09 Phase III trial. The study demonstrated improvement in progression-free survival (PFS) with Enhertu (trastuzumab deruxtecan, ADC) plus pertuzumab compared to taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer. The ADC combination reduced the risk of disease progression or death by 44% versus THP, with a median progression-free survival (PFS) of 40.7 months versus 26.9 months. And the median duration of response (DOR) for Enhertu plus pertuzumab was 39.2 months versus 26.4 months with THP.

Link: https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-plus-pertuzumab-reduced-the-risk-of-disease-progression-or-death-vs-thp-as-1st-line-therapy-in-patients-with-her2-positive-metastatic-breast-cancer.html

6. LY4170156 showed efficacy in platinum-resistant ovarian cancer, especially with the dosage of 4 mg/kg

On 2 June 2025, Eli Lilly and Company announced new Phase 1 data showing its folate receptor alpha (FRα) antibody-drug conjugate (ADC, LY4170156) demonstrated anti-tumour efficacy in women with heavily pre-treated platinum-resistant ovarian cancer.  In the 58 efficacy-evaluable patients, the overall objective response rate (ORR) was 45%, and the disease control rate was 74%. For patients receiving 4 mg/kg, the ORR was 55%, and this is the recommended dosage for the Phase II clinical trial.

Link: https://investor.lilly.com/news-releases/news-release-details/lilly-presents-first-clinical-data-its-investigational-next

7. Elinzanetant reduced vasomotor symptoms and improved quality of life in women with hormone receptor-positive breast cancer

On 2 June 2025, Bayer announced that results from the Phase III OASIS-4 study evaluating elinzanetant to treat vasomotor symptoms in women receiving endocrine therapy for the treatment or prevention of hormone receptor-positive breast cancer. In the study, elinzanetant reduced the frequency of VMS from baseline with −6.5 at week 4 and −7.8 at week 12 compared to -3.5 and -4.2 for the placebo group, respectively. Elinzanetant also significantly improved menopause-related quality of life and symptoms, with greater reductions in PROMIS SD SF 8b (-10.6 vs.-4.1) and MENQOL scores (-1.3 vs. -0.5) compared to placebo.

Link: https://www.bayer.com/media/en-us/elinzanetant-significantly-reduces-frequency-of-moderate-to-severe-vasomotor-symptoms-associated-with-endocrine-therapy-for-breast-cancer-in-phase-iii-oasis-4-study/

8. Simultaneous initiation of finerenone and empagliflozin reduces urine albumin-to-creatinine ratio in chronic kidney disease with type 2 diabetes

On 2 June 2025, Bayer announced results of the Phase II CONFIDENCE study showing that simultaneous initiation of finerenone (Kerendia™, mineralocorticoid receptor antagonist) and the SGLT-2-inhibitor (SGLT-2i) empagliflozin reduced urine albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 2 diabetes than monotherapy. The combination therapy reduced UACR  by 52% from the baseline, compared to 23% with finerenone alone and 20% with empagliflozin alone. Almost 75% of patients achieved the threshold of at least 30% reduction, which is 20% more than with either treatment alone. 

Link: https://www.bayer.com/media/en-us/simultaneous-treatment-start-with-finerenone-and-sglt-2-inhibitor-demonstrated-positive-data-in-patients-with-ckd-associated-with-type-2-diabetes/

9. IMDELLTRA® improves OS and PFS in small cell lung cancer after platinum chemotherapy

On 2 June 2025, Amgen announced new results from the global Phase 3 DeLLphi-304 trial investigating IMDELLTRA® (tarlatamab-dlle) in patients with small cell lung cancer (SCLC) who progressed on or after one line of platinum-based chemotherapy. It has been shown that the drug reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard-of-care (SOC) chemotherapy. At a median follow-up of 11.2 months for IMDELLTRA and 11.7 months for the control arm, the median OS was 13.6 months with IMDELLTRA compared to 8.3 months with local SOC chemotherapy. Median PFS was 4.2 months with IMDELLTRA compared to 3.7 months with local SOC chemotherapy.

Link: https://www.amgen.com/newsroom/press-releases/2025/06/imdelltra-significantly-reduced-risk-of-death-by-40-in-small-cell-lung-cancer-patients?_gl=1*15j5v5n*_up*MQ..*_ga*MTczNDgzMjk3My4xNzQ5NjMxMzk3*_ga_CBMSV0J9VL*czE3NDk2MzEzOTAkbzEkZzAkdDE3NDk2MzEzOTAkajYwJGwwJGgw

10. Updates on drug approvals

Company

Drug

Regulatory body

Target

Indication

Supported data

Roche

Evrysdi® (risdiplam) tablet

EU

SMN2 splicing modifier

Label extension for room-temperature stable tablet for spinal muscular atrophy (SMA). 

Bioequivalence study (NCT04718181) showed 5 mg tablet is bioequivalent to original dosage form

AstraZeneca

Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab

EU

selective inhibitor of Bruton’s tyrosine kinase

Previously untreated chronic lymphocytic leukaemia (CLL)

AMPLIFY Phase III trial: 77%–83% PFS at 3 years vs. 67% with standard chemoimmunotherapy

Bayer

Nubeqa™ (darolutamide)  in combination with androgen deprivation therapy (ADT)

FDA

Androgen receptor inhibitor (ARi) 

Metastatic castration-sensitive prostate cancer (mCSPC)

ARANOTE Phase III trial: darolutamide + ADT reduced risk of progression/death by 46% vs. placebo + ADT

Link: https://www.roche.com/media/releases/med-cor-2025-06-04

https://www.astrazeneca.com/media-centre/press-releases/2025/fixed-duration-calquence-approved-in-eu-for-1l-cll.html

https://www.bayer.com/media/en-us/us-fda-approves-third-indication-of-bayer-blockbuster-nubeqa-darolutamide-for-patients-with-advanced-prostate-cancer/