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

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

Economic Evaluation of the Organizational Impact of Atezolizumab Subcutaneous in a French Hospital (ISPOR-EU 2024) - "Atezolizumab SC treatment could allow time savings for hospitals during the preparation and the administration compared to IV treatments. Those time savings could be allocated to increase the capacity of the hospital to treat more patients."

Clinical • HEOR

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Bladder Cancer, Version 5.2024. (NCCN)

NCCN guideline • Bladder Cancer • Urothelial Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Hepatocellular Carcinoma, Version 3.2024. (NCCN)

NCCN guideline • Hepatocellular Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Soft Tissue Sarcoma, Version 3.2024. (NCCN)

NCCN guideline • Soft Tissue Sarcoma

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Cervical Cancer, Version 4.2024. (NCCN)

NCCN guideline • Cervical Cancer

NCCN has published updates to the NCCN Guidelines and the NCCN Compendium for Mesothelioma: Peritoneal, Version 2.2024. (NCCN)

NCCN guideline • Mesothelioma

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Non-Small Cell Lung Cancer, Version 10.2024. (NCCN)

NCCN guideline • Non Small Cell Lung Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Melanoma: Cutaneous, Version 3.2024. (NCCN)

NCCN guideline • Melanoma • Skin Cancer

Enhancing systemic anti-cancer treatment (SACT) capacity: implementing and using subcutaneous atezolizumab. (PubMed, Br J Nurs) - No abstract available

Journal • Oncology

FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy (Businesswire) - "Genentech...announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab). It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer....The FDA approval is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The Phase II IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab..."

FDA approval • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Soft Tissue Sarcoma

An Evidence-Based Rationale for Dose De-escalation of Subcutaneous Atezolizumab. (PubMed, Target Oncol) - "We have developed and evaluated two alternative dosing regimens that resulted in a cost reduction. Our weight-based dosing regimen can be directly implemented and complies with FDA guidelines for alternative dosing regimens of PD-L1 inhibitors. For the more progressive alternative dosing regimen aimed at the intratumoral PD-L1 receptor threshold, further evidence on efficacy and safety is needed before implementation."

Journal • Oncology

Pros and cons of subcutaneous (SC) versus intravenous (IV) administration of immune checkpoint inhibitors in non-small cell lung cancer. (PubMed, Transl Lung Cancer Res) - No abstract available

Checkpoint inhibition • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov) - P2/3 | N=49 | Terminated | Sponsor: Hoffmann-La Roche | N=440 ➔ 49 | Trial completion date: Jul 2026 ➔ Jul 2024 | Active, not recruiting ➔ Terminated; Study terminated by sponsor.

Enrollment change • HEOR • Trial completion date • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • PD-L1

ORIGAMA: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (clinicaltrials.gov) - P2/3 | N=440 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • HEOR • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • PD-L1

A phase II, multicenter, open-label study of polyPEPI1018 in combination with atezolizumab in participants with relapsed or refractory microsatellite-stable metastatic colorectal (MSS mCRC) cancer (Oberto-301). (ASCO 2024) - P2 | " Patients with MSS mCRC who have progressed on 2-3 lines of prior chemotherapy regimen received PolyPEPI1018 (1.2 mg, sc) and atezolizumab (1,200 mg, iv) Q3W until disease progression or unacceptable toxicity. PolyPEPI1018 in combination with atezolizumab was well-tolerated with no Grade 3 AEs observed. Despite no objective tumor responses could be detected, correlative data suggest contribution of PolyPEPI1018-induced immune responses to the modulation of tumor microenvironment and to improved disease control. The study did not proceed to stage 2; it is on-going for the collection of survival data."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Colorectal Cancer • Microsatellite Instability • Oncology • CD4 • CD8 • MSI

Subcutaneous delivery of immune checkpoint inhibitors: new route replacing intravenous administration? (PubMed, Transl Lung Cancer Res) - No abstract available

Checkpoint inhibition • Journal • Oncology

Brief Report: Updated Data From IMscin001 Part 2, a Randomized Phase III Study of Subcutaneous Versus Intravenous Atezolizumab in Patients With Locally Advanced/Metastatic NSCLC. (PubMed, J Thorac Oncol) - P3 | "In this analysis, mature OS data were similar between treatments. The updated efficacy and safety profile of subcutaneous atezolizumab is consistent with previous findings and equivalent to intravenous atezolizumab."

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