Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program (ENCOMPASS STUD)

Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Observational, Non-interventional Outcomes From a Multi-country Named Patient Access Program (ENCOMPASS STUDY)

Envafolimab is a novel PD-L1 inhibitor administered via subcutaneous (SC) injection - notably the first such checkpoint inhibitor approved for use worldwide.[1] In November 2021, Envafolimab received its first approval in China for adults with advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that have progressed after standard therapies. This SC route offers substantial practical advantages, significantly shortening treatment administration time and sparing patients from the adverse effects associated with intravenous infusions. Early clinical trials have demonstrated that Envafolimab can induce durable tumor responses, with objective response rates ~45% (including ~12% complete responses) observed in dMMR/MSI-H cancers. The therapy has also shown a favorable tolerability profile, with no infusion-related reactions and low rates of severe immune-mediated adverse events reported in initial studies.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Envafolimab

Detailed Description

The ENCOMPASS Study, designed to evaluate the real-world safety and effectiveness of Envafolimab in patients with advanced solid tumors. It is an observational, non-interventional, multicenter study sponsored by Glenmark Pharmaceuticals and will collect retrospective patient data from five countries: Kenya, Mauritius, Saudi Arabia, Philippines, and Sri Lanka. Approximately 120 adult patients treated under the Named Patient Program between June 2025 and December 2026 will be included. The primary endpoints focus on treatment effectiveness through Objective Response Rate (ORR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS). Secondary endpoints assess safety outcomes such as adverse events, serious adverse events, immune-related toxicities, and treatment discontinuation. Data will be gathered from anonymized medical records using electronic case report forms without any direct patient intervention. Statistical analysis will mainly be descriptive, with Kaplan-Meier methods used for survival outcomes. The study aims to generate evidence on Envafolimab use in non-Chinese populations where limited data currently exist. Ethical approvals, patient confidentiality, and regulatory compliance will be strictly maintained throughout the study.

• Study Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises adult cancer patients (aged ≥18 years) who were treated with Envafolimab through the NPP during the defined study period across the five countries.

Description

Inclusion Criteria:

1. Adult patients (≥ 18 years) who received at least one dose of Envafolimab under the NPP between June, 2025 and Dec 31, 2026.
2. Histologically or cytologically confirmed diagnosis of a malignancy for which Envafolimab was prescribed under the NPP (e.g., an advanced solid tumor with MSI-H/dMMR or other approved/compassionate indications).
3. Measurable or evaluable disease at baseline, with at least one disease assessment (e.g. imaging or clinical evaluation) performed within 8 weeks before the first Envafolimab dose (to establish baseline tumor status).
4. At least one post-baseline disease assessment after starting Envafolimab, and a minimum follow-up duration of 6 months from the first dose (unless the patient has documented disease progression or died within 6 months).
5. Availability of sufficient clinical data in the medical records to evaluate baseline characteristics, treatment administration, tumor response, and safety outcomes. This includes baseline demographics, disease status, treatment dates, and follow-up assessments as required by the CRF.
6. Permission/approval for data use: Patient data can be utilized for research as per local ethical and regulatory requirements (e.g., institutional review board approval or waiver of consent for retrospective data collection, and compliance with data privacy laws).

Exclusion Criteria:

1. No evidence of Envafolimab administration: Patients for whom Envafolimab was requested or planned under NPP but never actually received a dose.
2. Insufficient follow-up: Patients with no post-baseline tumor assessment and less than 6 months of follow-up without documented disease progression or death. (Such patients would not contribute evaluable data for effectiveness.)
3. Missing critical baseline information in records, such as unknown index (start) date of Envafolimab therapy or lack of documented cancer diagnosis, precluding assessment of outcomes.
4. Prior Envafolimab exposure outside the NPP (e.g., via a clinical trial or other program) before the index date, unless specifically allowed (pre-specified exceptions, if any, will be outlined for instance, patients who switched from a clinical trial to NPP might be handled on a case by case basis).
5. Concurrent participation in any other interventional clinical trial at the time of starting Envafolimab (index date), to avoid confounding effects of other investigational treatments on outcomes.
6. Legal or ethical prohibitions on using the patient's data for research. For example, if local regulations or the patient's prior consent status prevent inclusion of their de-identified data in this study, they will not be enrolled.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Envafolimab (200mg/ml)	Drug: Envafolimab; In this study, there is no active intervention because it is an observational, non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR)	: The proportion of patients who achieve CR, PR, or Stable Disease (SD) as the best response. DCR provides a measure of the fraction of patients who derive any tumor control (no progression) from the therapy.	From first dose through up to 6 months follow-up
Progression-Free Survival (PFS)	: Defined as the time from first Envafolimab dose to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS for each patient (in months) will be calculated based on dates recorded in the CRF. Patients without documented progression who are alive at the last follow-up will be censored at the date of the previous disease assessment.	From first dose through up to 6 months follow-up
Overall Survival (OS)	Defined as the time from first Envafolimab dose to death from any cause. OS (in months) will be determined for each patient; living patients will be censored at the date of last contact or last known alive date.	From first dose through up to 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)	The proportion of patients experiencing any adverse event (of any grade) during the observation period after starting Envafolimab. This will be captured by whether "Any Adverse Events reported" is marked on the CRF.	From first dose through up to 6 months follow-up
Incidence of Grade ≥3 AEs	The frequency of patients who experienced severe or lifethreatening adverse events (Grade 3 or higher, as per CTCAE v5.0) during Envafolimab treatment.	From first dose through up to 6 months follow-up
Incidence of Serious Adverse Events (SAEs)	The proportion of patients with any serious adverse event (as defined by standard criteria: results in death, is life-threatening, requires/prolongs hospitalization, or other medically important events) reported during treatment.	From first dose through up to 6 months follow-up
Incidence of immune-related adverse events (irAEs)	The proportion of patients who experienced immune-mediated toxicities (e.g., autoimmune manifestations such as pneumonitis, colitis, etc.) attributed to Envafolimab.	From first dose through up to 6 months follow-up
Treatment discontinuation due to AEs	The percentage of patients who had Envafolimab therapy permanently stopped as a result of adverse events.	From first dose through up to 6 months follow-up

Collaborators and Investigators

• Sponsor: IR INNOVATE RESEARCH PRIVATE LIMITED
• Collaborators: Glenmark Pharmaceuticals Ltd. India

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: envafolimab
• Other Study ID Numbers: NIS/2025/40 (Other Identifier: Glenmark Pharmaceuticals Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No