Tecentriq (atezolizumab) / Roche - LARVOL DELTA

Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial. (PubMed, JAMA) - P3 | "The addition of the immune therapy drug atezolizumab to chemotherapy after surgery did not provide benefit among patients with triple-negative breast cancer who are at high risk of recurrent disease. ClinicalTrials.gov Identifier: NCT03498716."

Clinical • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

SKYSCRAPER-01: A phase III, randomized trial of tiragolumab (tira) + atezolizumab (atezo) versus placebo (pbo) + atezo in patients (pts) with previously-untreated PD-L1-high, locally advanced unresectable/metastatic NSCLC (AACR 2025) - P3 | "The primary endpoints of INV-PFS and OS were not met in the SKYSCRAPER-01 study. Numerical improvements in both PFS and OS with tira + atezo versus pbo + atezo suggest potential antitumor activity of TIGIT targeting in NSCLC.TablePAS (TPS ≥50% per 22C3 assay)Tira + atezo(n=262)Pbo + atezo(n=259)Median PFS, months (95% CI)*†7.0 (5.6, 9.8)5.6 (4.4, 7.0)HR (95% CI); p-value0.78 (0.63, 0.97); p=0.02Median OS, months (95% CI)*†23.1 (17.7, 28.8)16.9 (14.6, 23.1)HR (95% CI); p-value0.87 (0.71, 1.08); p=0.22ORR, %*45.835.1Median DOR, months (95% CI)*18.0 (13.6, 24.4)14.6 (9.7, 18.6)SAS (TC ≥50% per SP263 assay)Tira + atezo(n=211)Pbo + atezo(n=209)Median OS, months (95% CI)*24.6 (17.9, 32.0)20.6 (16.6, 29.3)HR (95% CI)0.93 (0.73, 1.18)Safety evaluable set‡Tira + atezo(n=267)Pbo + atezo(n=263)Any grade AEs, %95.991.3Grade 3-4 AEs, %41.233.8Grade 5 AEs, %10.99.9Treatment-related grade 5 AEs, %1.50.8AEs leading to treatment withdrawal, %16.16.5Any grade AESIs, %70.050.6*PFS..."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1 • TIGIT

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). (ASCO 2025) - P3 | "The phase III ATOMIC trial (NCT02912559) was conducted to determine whether atezolizumab (atezo), an anti-PD-L1 antibody, can improve pt outcomes when added to adjuvant 5-fluorouracil, leucovorin plus oxaliplatin (mFOLFOX6) in pts with stage III dMMR tumors. The addition of atezolizumab to mFOLFOX6 significantly improved DFS and should be considered the new adjuvant standard of care for patients with dMMR stage III colon cancer. Support: U10CA180821, U10CA180882, U24CA196171; Genentech, a member of the Roche group; https://acknowledgments.alliancefound.org."

Clinical • dMMR • Late-breaking abstract • Mismatch repair • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Pediatrics • Solid Tumor

Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients. (ASCO 2025) - P1/2 | "These data suggest that the combination of DSP107 with PD(L)1 blockade has anti-tumor activity and provides clinical benefit in third line metastatic MSS CRC including in patients with liver metastases. Updated survival data will be presented at the conference. A Phase 2 randomized controlled study is currently in planning to confirm this preliminary efficacy signal."

Clinical • Metastases • P2 data • Anemia • Colorectal Cancer • Fatigue • Hepatocellular Cancer • Oncology • Solid Tumor • CD47 • SIRPA

Genomic characterization of baseline and post-progression tumors in IMmotion010, a randomized, phase 3 study of adjuvant (adj) atezolizumab (atezo) vs placebo (pbo) in patients (pts) with high-risk localized renal cell carcinoma (RCC). (ASCO 2025) - P3 | "This is the first report of tissue genomic profiling in a phase 3 adjuvant immune checkpoint inhibitor study in RCC. While certain molecularly defined subsets may carry predictive value, serum KIM-1 remains the most robust predictor of outcome with atezo. Analyses of progression biopsies highlight an evolution in genomic profile and offer insights into mechanisms of relapse."

Clinical • IO biomarker • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • KIM1

Evaluation of hyperprogressive disease with atezolizumab plus bevacizumab for hepatocellular carcinoma: A secondary analysis of the IMbrave150 trial. (PubMed, Int J Cancer) - "For all definitions of early progression/treatment failure, the risk was either significantly lower with atezolizumab plus bevacizumab than with sorafenib, or there were no differences. Atezolizumab plus bevacizumab treatment is unlikely to cause significant HPD."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • AFP

Atezolizumab plus bevacizumab and chemotherapy in metastatic nonsquamous NSCLC: the randomized double-blind phase 3 IMpower151 trial. (PubMed, Nat Med) - P3 | "Chemotherapy-naive patients with metastatic nsqNSCLC (N = 305) were randomized 1:1 to receive either atezolizumab, bevacizumab, carboplatin and paclitaxel or pemetrexed (ABCPem/Pac; n = 152) or placebo plus bevacizumab, carboplatin and pemetrexed or paclitaxel (BCPem/Pac; n = 153). ABCPem/Pac was generally well tolerated, with no new safety signals. Trial registration number: ClinicalTrials.gov, NCT02366143."

Journal • P3 data • Endocrine Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Validation of a 15-Gene Prognostic Signature in Metastatic Clear Cell Renal Cell Carcinoma. (PubMed, JCO Precis Oncol) - "The 15G score was independently prognostic in metastatic ccRCC among patients receiving different systemic therapy regimens."

Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy according to PD-L1 status in the BEATcc (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030) randomised phase III trial of first-line atezolizumab (atezo), chemotherapy (CT) and bevacizumab (bev) for metastatic, persistent or recurrent cervical cancer (R/M CC) (ESMO-GC 2025) - P3 | "Editorial acknowledgement J. Kelly (Medi-Kelsey Ltd). Legal entity responsible for the study GEICO."

Clinical • IO biomarker • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Brief Report: Post Hoc Validation of Platinum Ineligibility in NSCLC From the Phase III IPSOS Study. (PubMed, J Thorac Oncol) - P3 | "This subanalysis suggests that first-line treatment with atezolizumab provides long-term OS, consistent with the results from the ITT population, and a favorable safety profile compared with single-agent chemotherapy in the sPI population. Additionally, the selection criteria for platinum ineligibility from the sPI population may provide a structured approach for treatment selection in NSCLC in clinical practice."

Journal • P3 data • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Digital Versus Manual PD-L1 Scoring in Advanced Non-Small Cell Lung Cancer From the IMpower110 and IMpower150 Trials. (PubMed, J Thorac Oncol) - "AIM-PD-L1 digital SP263 PD-L1 scoring is concordant with manual scoring showing similar predictivity for benefit and could potentially be used as a predictive marker for patient stratification and selection for anti-PD-(L)1 therapy."

IO biomarker • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Safety and Survival Update of Tarlatamab with Anti-PD-L1 as 1L Maintenance After Chemo-IO for ES-SCLC: DeLLphi-303 Ph1b Trial (IASLC-WCLC 2025) - P1, P3 | "Methods : Patients with ES-SCLC were eligible if they had completed 4 to 6 cycles of 1L platinum-etoposide chemotherapy and anti-PD-L1 (unless unavailable) without disease progression. Within 8 weeks from the start of the last chemo-immunotherapy cycle, patients received tarlatamab (10 mg IV Q2W) with either atezolizumab (1680 mg IV Q4W) or durvalumab (1500 mg IV Q4W) as 1L maintenance until disease progression...The median OS was 25.3 months (95% CI, 20.3-not reached) and the median PFS was 5.6 months (95% CI, 3.5-9.0) (Figure). Conclusions Tarlatamab in combination with anti-PD-L1 demonstrated an acceptable safety profile, with long-term tolerability and unprecedented OS."

Clinical • Lung Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

First-Line Atezolizumab Plus Chemotherapy in Elderly Patients With Advanced NSCLC, IFCT-1805 Elderly: A Randomized, Multicenter, Phase 3 Trial (IASLC-WCLC 2025) - "The IFCT-1805 ELDERLY trial assessed the addition of atezolizumab (ATZ), an ICI targeting the human programmed death-ligand 1 (PD-L1), to the current standard of care by monthly carboplatin with weekly paclitaxel CT (E Quoix et al, Lancet 2011) in elderly patients with advanced NSCLC. Conclusions : In the IFCT-1805 ELDERLY trial, despite a numerically longer OS when adding ATZ to the current standard of care CT for first line therapy of elderly patients with NSCLC, the gain was not statistically significant. However, the addition of ATZ to CT significantly improved the PFS, the ORR and the DOR regardless of PD-L1 expression."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR

ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-Small Cell Lung Cancer (IASLC-WCLC 2025) - "Introduction : IMpower130 study demonstrated efficacy of atezolizumab plus chemotherapy (chemo) over chemo alone...This study, for the first time, evaluated serplulimab (anti-PD-1 antibody) plus HLX04 (bevacizumab biosimilar) and chemo (pemetrexed plus carboplatin) versus serplulimab plus chemo in nsNSCLC...Conclusions : The addition of serplulimab to chemo provided significantly longer PFS compared to chemo alone in patients with locally advanced or metastatic nsNSCLC, while the combination of serpluliamb, bevacizumab and chemo provided numerical improvements in PFS when compared to serplulimab and chemo. Both treatment regimens had manageable safety profiles."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. (PubMed, Lancet Oncol) - P1, P3 | "Tarlatamab plus a PD-L1 inhibitor as maintenance after first-line chemo-immunotherapy showed a manageable safety profile with promising anticancer activity, supporting the ongoing phase 3 trial (NCT06211036)."

Journal • P1 data • Hematological Disorders • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • DLL3

Zanzalintinib plus atezolizumab (zanza + atezo) vs regorafenib (rego) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): Primary overall survival (OS) analysis from the randomized, open-label, phase III STELLAR-303 study (ESMO 2025) - P3 | "Conclusions Zanza + atezo significantly improved OS vs rego with no new safety signals, representing a potential new treatment option for pts with previously treated mCRC. The trial continues to the final OS analysis in the nlmITT population."

Clinical • Late-breaking abstract • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • AXL • MSI

IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (ESMO 2025) - P3 | "The atezo safety profile was tolerable, with no new findings. Pts who persistently tested ctDNA− had low risk of recurrence."

Circulating tumor DNA • Clinical • Late-breaking abstract • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

DAREON®-8: A phase I trial of first-line obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC) (ESMO 2025) - P1 | "We report the first safety and efficacy data for the dose escalation part of the Phase I DAREON®-8 (NCT06077500) trial investigating obrixtamig + first-line (1L) SoC (carboplatin + etoposide + atezolizumab) in patients (pts) with ES-SCLC. The frequency and severity of AEs reported for the combination were consistent with the expected safety findings of the individual treatments. The combinability of obrixtamig with chemotherapy and an anti-PDL1 antibody observed in this trial warrant further development of this combination in 1L ES-SCLC."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC) (ESMO 2025) - P3 | "Median OS were not reached. Grade ≥3 treatment-related adverse events occurred in 8.8% and 22.7% of patients in Arm A and Arm B. The most common were cystitis (1.2%) in Arm A, and urinary tract disorder (2.0%) and pollakiuria (1.2%) in Arm B. Conclusions ALBAN trial did not demonstrate benefit from adding atezolizumab to BCG in BCG-naive high-risk NMIBC."

Clinical • Late-breaking abstract • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology

IMbrave152/SKYSCRAPER-14: A phase III study of first-line tiragolumab (tira) + atezolizumab (atezo) + bevacizumab (bev) vs placebo (pbo) + atezo + bev for patients (pts) with untreated locally advanced or metastatic hepatocellular carcinoma (HCC) (ESMO 2025) - P3 | "OS data are not expected to reach statistical significance. The study has been unblinded and long-term survival follow-up is ongoing."

Clinical • Late-breaking abstract • Metastases • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • TIGIT

Adding ipilimumab (IPI) to atezolizumab (ATEZO) plus bevacizumab (BEV) in patients (pts) with unresectable hepatocellular carcinoma (uHCC) in first-line systemic therapy (1L): PRODIGE 81/FFCD 2101 - TRIPLET HCC (ESMO 2025) - P2/3 | "Efficacy seemed to be similar between both arms whereas tolerance tended to be better in arm B. Finally, adding IPI at low dose (1 mg/kg) did not add benefit to ATEZO/BEV. A longer follow-up is needed to better assess the impact of IPI on OS, especially on the rate of long survivors."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Liver resection versus continued atezolizumab plus bevacizumab (atezo/bev) in locally advanced hepatocellular carcinoma (HCC) after atezo/bev treatment (TALENTop): A multicenter, open-label, randomized phase III trial (ESMO 2025) - P | "Grade ≥ 3 atezo/bev-related adverse events occurred in 27.7% of pts in arm A vs. 21.0% in arm B. Grade ≥ 3 surgical complication rate was 21.7%. Conclusions For locally advanced HCC pts with PR or SD and eligible for resection after initial atezo/bev treatment, liver resection provided statistically significant and clinically meaningful benefits and showed a trend toward OS benefit compared to continued atezo/bev treatment."

Clinical • Metastases • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

IKF-035/ABC-HCC: A phase IIIb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma (ESMO 2025) - P3 | "The IMbrave150 phase 3 study showed that the combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF antibody bevacizumab (atezo/bev) extend survival compared to sorafenib in 1L treatment of advanced and intermediate HCC failing/unsuited for TACE. Conclusions The first IA provides important insights into the efficacy of atezo/bev vs. TACE in intermediate stage HCC. Based on these findings, the trial is progressing to the 2nd IA at 66% information time (169 events)."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

SKYSCRAPER-07: A phase III, randomised study of atezolizumab (atezo) with or without tiragolumab (tira) in patients (pts) with unresectable esophageal squamous cell carcinoma (ESCC) that has not progressed following definitive concurrent chemoradiotherapy (dCRT) (ESMO 2025) - P3 | "No new safety signals were identified. Table: 2094O PFS OS A Tira + atezo (N=257) B Atezo + pbo (N=250) C Pbo + pbo (N=253) A Tira + atezo (N=257) B Atezo + pbo (N=250) C Pbo + pbo (N=253) Pts with event, n (%) 141 (54.9) 128 (51.2) 157 (62.1) 111 (43.2) 88 (35.2) 118 (46.6) Median, m (95% CI) 20.8 (13.9–28.8) 29.1 (19.0–36.3) 16.6 (11.2–19.4) 38.6 (28.8–NE) NR 36.4 (25.8–NE) Stratified HR* (95% CI) 0.82 (0.65–1.03) 0.74 (0.58–0.93) † – 0.91 (0.70–1.18) † 0.69 (0.52–0.91) † – P-value* 0.0947 0.0113 † – 0.4772 † 0.0085 † – 24 m rate, % (95% CI) 46.7 (40.3–53.0) 52.8 (46.4–59.2) 40.9 (34.6–47.1) 59.9 (53.6–66.1) 69.1 (63.2–75.0) 59.4 (53.1–65.7) *Vs placebo † Not formally tested as PFS (A vs C) not met, p-values are descriptive m, months; NE, not estimable; NR, not reached"

Clinical • P3 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

SKYSCRAPER-09: Phase II, randomised study of tiragolumab (tira) + atezolizumab (atezo) and atezo + placebo (pbo) as first-line (1L) treatment in patients (pts) with recurrent/metastatic PD-L1+ squamous cell carcinoma of the head and neck (R/M SCCHN) (ESMO 2025) - P2 | "Background The current standard of care for R/M PD-L1+ SCCHN is pembrolizumab. A numerical improvement in OS was observed with tira + atezo vs atezo + pbo; this was driven by the PD-L1-high subgroup and may be clinically meaningful. Table: 1348MO PD-L1+ (TAP ≥5%)* PD-L1-high (TAP ≥20%) Tira + atezo (n=80) Atezo + pbo (n=39) Tira + atezo (n=41) Atezo + pbo (n=22) ORR, † n (%) [95% CI] 17 (21.3) [13.2, 32.1] 6 (15.4) [6.4, 31.2] 12 (29.3) [16.7, 45.7] 3 (13.6) [3.6, 36.0] Median PFS, m (95% CI) 4.1 (2.9, 7.0) 3.0 (1.5, 7.1) 5.8 (2.8, 9.6) 4.0 (2.7, 9.0) Median OS, m (95% CI) 16.2 (12.7, 19.9) 13.6 (8.8, 18.9) 22.7 (16.9, NE) 10.0 (6.8, 18.7) *Intent-to-treat population † Investigator-assessed CI, confidence interval; NE, not estimable"

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1