Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) / Roche, Halozyme - LARVOL DELTA

IMscin002 patient population included in Spain, an analysis of patient preference and satisfaction with atezolizumab SC formulation (ESMO-IO 2025) - P2 | "Nurses also reported a reduced time in SC management in the treatment room in comparison to IV. These results are comparable with the ones reported in the full IMscin002 global cohort.Legal entity responsible for the study Roche Farma S.A."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. (PubMed, Oncol Ther) - P2 | "Most patients preferred atezolizumab SC regardless of baseline characteristics, mean injection duration, and cumulative number of SC injections. The trend for a stronger preference was higher among patients who preferred SC than those who preferred IV. Our findings suggest that the proportion of preference for atezolizumab SC over IV is highest in patients aged > 74 years, and that administrator's experience could be an important factor influencing patient preference."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer (Springer) - "Among 179 patients randomized, demographics and characteristics were generally balanced between arms. Overall, 87/123 patients (70.7%) preferred atezolizumab SC, of whom 86.2% had a very/fairly strong preference compared with 69.2% of patients who preferred IV (n = 26/123, 21.1%). Patient preference for atezolizumab SC was independent of baseline characteristics and mean injection duration. A higher proportion of preference was seen in patients aged > 74 years (87.5%)."

P2 data • Non Small Cell Lung Cancer

Real-World Evidence Study on the Resource Impact of Subcutaneous vs. Intravenous Atezolizumab in an NHS Cancer Center (ISPOR-EU 2025) - "This study demonstrates that SC atezolizumab compared to IV delivery significantly reduces CTU chair time. Further research is warranted into the potential clinical implications for increased service capacity and more efficient use of service resources."

Clinical • HEOR • Real-world • Real-world evidence • Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium), and the NCCN Radiation Therapy Compendium for Thymomas and Thymic Carcinomas, Version 1.2026. (NCCN)

NCCN guideline • Thymic Carcinoma • Thymoma

Jazz Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy... (PRNewswire) - "The FDA approval is based on results from the Phase 3 IMforte trial (NCT05091567), which showed that the Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone."

FDA approval • Small Cell Lung Cancer

IMscin002 Final Analysis: Patient Preference and Safety of Atezolizumab by Subcutaneous and Intravenous Administration (IASLC-WCLC 2025) - P2, P3 | "Conclusions : No new or unexpected safety findings were observed. Longer term data support that most patients prefer atezolizumab SC versus IV, and that atezolizumab SC has similar efficacy, PROs, and a similar safety profile to atezolizumab IV."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • PD-L1

India clears Roche’s 7-minute cancer injection Tecentriq for patients, with Phase IV trial condition (The Economic Times) - "Roche has received clearance to import and market Atezolizumab injection (Tecentriq) for subcutaneous administration in India, potentially reducing cancer treatment time and costs. The approval, granted by a technical committee, requires Roche to conduct a Phase IV clinical trial in India."

Approval • Alveolar Soft Tissue Sarcoma • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Triple Negative Breast Cancer • Urothelial Cancer

Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: University of Southern California | N=37 ➔ 5 | Trial completion date: Dec 2026 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Jul 2025; insufficient accrual

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Guidelines Navigator, and the NCCN Drugs & Biologics Compendium (NCCN Compendium), Version 4.2025. (NCCN)

dMMR • NCCN guideline • Colon Cancer • Microsatellite Instability

Decentralising delivery of systemic anti-cancer therapy (SACT) with subcutaneous atezolizumab: service challenges, opportunities and case studies. (PubMed, Br J Nurs) - No abstract available

Journal • Oncology

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Antiemesis, Version 2.2025. (NCCN)

NCCN guideline • Multiple Myeloma • Oncology • Solid Tumor

Decentralising delivery of systemic anti-cancer therapy (SACT) with subcutaneous atezolizumab: service challenges, opportunities and case studies. (PubMed, Br J Nurs) - "With sufficient workforce training and flexibility, decentralisation could produce a lasting improvement in outcomes. Six case studies are presented highlighting successful examples of service decentralisation using subcutaneous (SC) atezolizumab, covering their impacts on patients."

Journal • Oncology

Primary Results from IMscin002: A Study to Evaluate Patient Preferences and Perceptions of Health Care Professionals for Atezolizumab Subcutaneous Versus Intravenous for the Treatment of NSCLC. (PubMed, JTO Clin Res Rep) - P2 | "There were no new safety findings, and switching between the administration routes was well tolerated. These results support the preference for SC formulations to reduce the treatment burden."

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

Evaluation of Patients Experience of ReceivingImmunotherapy (IO) (BTOG 2025) - "Introduction: Following NICE approval of Atezolizumab as a subcutaneous (SC) injection, some NHS Chemo-Day Units (CDU) have switched Atezolizumab from intravenous to SC formulation... 20 surveys were conducted on patients receiving all types of mono-IO therapy: •35% of patients feel the frequency of hospital visits affect their life; 26% feel it affect their family's life.•25% of patients feel time spent in hospital for IO affecting their life; 35% feel it affect their family's life.•45% of patients attend appt and treatment with family and carers.•55% of patients spend 1–3 hours, one way, travelling to hospital for appointment.• 31% of patients spend >2 hours at CDU on the day of IO. 39 treatment episodes were audited, (excluding C1), to identify'fit note'to'needle time':"

Clinical

Patient experiences of atezolizumab subcutaneous formulation compared to intravenous in Newcastle, and the impact on services delivering systemic anti-cancer treatments (BTOG 2025) - "All patients receiving atezolizumab monotherapy or combination therapy in Newcastle were eligible, excluding patients with breast cancer receiving combination therapy with atezolizumab and paclitaxel albumin. Overall, the switch to the SC formulation of atezolizumab had a positive impact on both patients, and the teams delivering SACT. The SC formulation was generally preferred by patients and it had a positive impact on unit capacity."

Clinical • Breast Cancer • Oncology • Pain • Solid Tumor

Population Pharmacokinetics and Exposure-Response of Subcutaneous Atezolizumab in Patients With Non-Small Cell Lung Cancer. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "For all efficacy and safety endpoints, atezolizumab exposure was not statistically significant (p-value > 0.05) in the ER models. The non-inferior popPK exposure and flat ER results supported atezolizumab SC dose at 1875 mg q3w."

Journal • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IMscin001: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=438 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Halozyme Reiterates 2024 Financial Guidance and Raises 2025 and Multi-Year Financial Guidance (PRNewswire) - "Halozyme Therapeutics, Inc...provided a financial update, reiterating full year 2024 financial guidance and raising full year 2025 and multi-year financial guidance. The Company also announced it has recently entered into a new $250 million accelerated share repurchase (ASR) program under its previously announced $750 million share repurchase program...Our 2025 guidance, with projected revenue growth of 16% to 23% and adjusted EBITDA growth of 24% to 32%, is largely driven by VYVGART Hytrulo, which has received strong early acceptance in generalized myasthenia gravis, and is now seeing growing adoption in CIDP following the June 2024 U.S. approval, and by the continued strong growth of Darzalex SC and Phesgo. Three additional products, Ocrevus Zunovo, Tecentriq Hybreza and Opdivo Qvantig, which are in the early stages of commercialization following recent approvals, are projected to contribute modestly in 2025, growing meaningfully from 2026 onwards."

Commercial • Breast Cancer • Multiple Myeloma • Multiple Sclerosis • Myasthenia Gravis • Non Small Cell Lung Cancer • Solid Tumor

Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully complete negotiations for TECENTRIQ SC (atezolizumab, solution for subcutaneous injection) (Canada Newswire) - "Hoffmann-La Roche Limited (Roche Canada) today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for TECENTRIQ SC (atezolizumab) on November 19, 2024. The pCPA negotiates on behalf of the provinces and territories, making the end of these negotiations a critical step in bringing TECENTRIQ SC closer to public access....Reaching this important milestone is the result of close collaboration with pCPA and further emphasizes the need to move quickly through the subsequent steps to public reimbursement. The next step will be for provincial and territorial governments to make the final decision on public reimbursement for their regions."

Reimbursement • Hepatocellular Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Plenary: Improving patient convenience and healthcare efficiencies with subcutaneous atezolizumab (ESMO Asia 2024) - "Sponsored By Roche"

Clinical • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Patient satisfaction and preference for atezolizumab subcutaneous (atezo SC) by body mass index (BMI) or race (Asian vs non-Asian) from IMscin001 and IMscin002 (ESMO Asia 2024) - P2, P3 | "Table: 62P % IMscin002 BMI quartiles 1 2 3 4 Preferred method n 30 30 30 33 IV 20.0 26.7 23.3 15.2 SC 73.3 63.3 63.3 81.8 No preference 6.7 10.0 13.3 3.0 Treatment choice n 26 25 27 29 IV 19.2 28.0 22.2 13.8 SC 80.8 72.0 77.8 86.2 SC satisfaction n 31 33 30 33 Satisfied/very satisfied 80.6 84.8 90.0 87.9 Not satisfied or dissatisfied 12.9 9.1 10.0 12.1 Dissatisfied/very dissatisfied 6.5 6.1 0 0 IMscin001 BMI quartiles 1 2 3 4 SC satisfaction n 37 37 43 38 Satisfied/very satisfied 78.4 86.5 83.7 84.2 Not satisfied or dissatisfied 18.9 13.5 7.0 10.5 Dissatisfied/very dissatisfied 2.7 0 9.3 5.3 Asian Non-Asian n 30 129 Satisfied/very satisfied 86.7 82.2 Not satisfied or dissatisfied 10.0 13.2 Dissatisfied/very dissatisfied 3.3 4.7 Conclusions In this analysis, across both IMscin001 and IMscin002 trials, BMI did not play a role in pt satisfaction or preference for atezo SC. Data from the IMscin001 trial did not show any impact of race (Asian vs non-Asian) on patient..."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Small Cell Lung Cancer, Version 3.2025. (NCCN)

NCCN guideline • Small Cell Lung Cancer

Systematic Literature Review of Hospital Time and Resource Consumption in Subcutaneous and Intravenous Oncologic Biologic Therapies: The Case Study of Atezolizumab From an Italian Perspective (ISPOR-EU 2024) - P3 | "Administering atezolizumab SC instead of IV could result in cost savings for Italian hospitals by reducing HCP time for drug preparation and administration, thereby enhancing overall efficiency and financial sustainability."

Case study • Clinical • Review • Oncology

IMscin002: A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1