FDA Supports Continued Cancer Vaccine Research in Advanced/Metastatic NSCLC

The FDA and European Medicines Agency (EMA) expressed supported for the continued research of cancer vaccine OSE2101 (Tedopi) for advanced or metastatic non–small cell lung cancer (NSCLC) via a new confirmatory phase 3 trial, according to a regulatory update from an FDA Type C meeting.

“We are pleased with the positive outcomes from the FDA Type C Meeting following the supportive EMA advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of [OSE2101],” according to the manufacturers of OSE2101.

The FDA and EMA’s regulatory decisions follow clinical data from the initial phase 3 ATALANTE trial (NCT02654587) which highlighted the clinical efficacy of OSE2101 as third-line treatment for NSCLC after secondary resistance to immune checkpoint inhibitors.

In the ATALANTE trial, OSE2101 yielded a significant improvement in the primary end point of 1-year overall survival (OS) at 44.4% vs 27.5% among those who received chemotherapy-based standard of care (P = .017).

Additionally, OSE2101 produced an improved safety profile over chemotherapy, with 11% of patients having grade 3 to 5 adverse effects vs 35%, respectively (P <.05). OSE2101 also led to better quality of life among patients in the experimental arm vs the control arm in terms of global health status (P = .045) and role functioning (P = .025).

“We are pleased with the positive outcomes from the FDA Type C Meeting following the supportive EMA advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of [OSE2101],” Nicolas Poirier, chief executive officer of OSE Immunotherapeutics, said in the press release.

Investigators of the randomized phase 3 ATALANTE trial compared the efficacy of the OSE2101 vaccine with standard-of-care chemotherapy in patients with advanced or metastatic NSCLC. In the experimental arm, patients received OSE2101 at a dose of 1 ml via subcutaneous injection on day 1 every 3 weeks for 6 cycles then every 8 weeks for the remainder of the first year until disease progression.

In the comparator arm, patients received 75 mg/m² of docetaxel via intravenous infusion or 500 mg/m² of pemetrexed as an intravenous infusion on day 1 of a 21-day cycle.

Secondary end points of the trial included the disease control rate, quality of life, progression-free survival, objective response rate, duration of response, and safety and tolerability.

Patients 18 years and older with histologically or cytologically confirmed stage III or IV NSCLC and disease recurrence or progression following treatment with an immune checkpoint inhibitor were eligible for enrollment. Additional inclusion criteria included having measurable or non-measurable lesions, an ECOG performance status of 0 or 1, and adequate organ function.

Patients with SCLC, mixed NSCLC, or squamous cell carcinoma histology were not able to enroll on the trial. Patients were also unsuitable for enrollment if they had tumors harboring EGFR mutations, spinal cord compression, treatment with corticosteroids within 3 weeks prior to beginning study treatment, or evidence of other active invasive cancers other than NSCLC.

Investigators are also assessing OSE2101 in ongoing phase 2 trials. The CombiTED study (NCT04884282) will evaluate OSE2101 as a second-line treatment in metastatic NSCLC following chemotherapy.

Additionally, the phase 2 TEDOPaM study (NCT03806309) will assess the OSE2101 vaccine in combination with folinic acid, fluorouracil, and irinotecan hydrochloride (FOLFIRI) vs FOLFIRI alone as maintenance therapy among patients with advanced or metastatic pancreatic adenocarcinoma.

Investigators are also exploring OSE2101 as a single agent or in combination with pembrolizumab (Keytruda) vs best supportive care in patients with platinum-sensitive recurrent ovarian cancer in the phase 2 TEDOVA study (NCT04713514).

Reference

OSE Immunotherapeutics provides regulatory update on Tedopi^®, a cancer vaccine at a late-stage clinical development in lung cancer after failure to immunotherapies. News release. OSE Immunotherapeutics. February 15, 2023. Accessed February 17, 2023. yhoo.it/3lJgK2f