Early Phase 3 Trial Results of Tedopi for Advanced NSCLC Are Positive

Early Phase 3 Trial Results of Tedopi for Advanced NSCLC Are Positive

Early results from the ATALANTE-1 Phase 3 trial indicate that Tedopi benefits people with advanced non-small cell lung cancer (NSCLC) who failed to respond to prior checkpoint inhibitor therapy, OSE Immunotherapeutics reported.

Three enrolled patients responded positively to third-line treatment with Tedopi, either achieving a partial reduction of their tumors or experiencing stable disease, with a good safety profile.

The findings were revealed at the recent American Association of Cancer Research (AACR) 2019 Annual Meeting in Atlanta, Georgia, in the presentation “Early signs of activity of Tedopi OSE2101, a multiple neoepitope vaccine, in a phase 3 trial in advanced lung cancer patients after failure to previous immune checkpoint inhibitors ATALANTE-1.

Tedopi is a cancer vaccine being developed by OSE Immunotherapeutics for the treatment of NSCLC and pancreatic cancer. It contains 10 neo-epitopes — small proteins optimized to mimic five tumor-associated antigens frequently expressed in lung cancer cells. Tedopi works by exposing those antigens to the immune system, stimulating it to recognize and kill cancer cells.

In an earlier Phase 2 trial, Tedopi led to outstanding survival rates among lung cancer patients with brain metastasis who had received several prior lines of therapy. 

Thus, OSE designed ATALANTE-1 (NCT02654587) to determine whether Tedopi is more effective at extending overall survival than standard chemotherapy — Taxotere (docetaxel) or Alimta (pemetrexed) — in advanced NSCLC patients.

Taking place at multiple centers in the U.S., Europe, and Israel, the trial is evaluating Tedopi as treatment for HLA-A2 positive patients at an advanced stage who failed to respond to one or two prior treatments with PD-1/PD-L1 immune checkpoint inhibitors.

The results presented at the AACR annual meeting describe the cases of three patients enrolled in the trial who achieved a clinical benefit with Tedopi.

After a treatment duration that ranged from 4.9 to more than 12 months, one patient achieved a partial response and two others reached stable disease as defined by RECIST 1.1 criteria.

Partial response means that tumors shrank at least 30%. Stable disease describes a condition where tumors neither shrank enough to qualify for a partial response nor grew significantly enough to be considered progressive disease (20% increase or higher).

According to the presentation, all patients have been free of cancer progression over 4.2, 11, and 18.1 months, respectively, including one who reached stable disease and had his cancer spread to the brain (brain metastases).

Also, Tedopi’s safety profile was good for all three patients, and so far none has withdrawn because of toxicity.

So far, 18 patients have been enrolled in the Tedopi group. Tedopi is administered as a 5 mg dose injected subcutaneously (under the skin) every three weeks for six cycles, then every two months for the remainder of the first year. Thereafter, Tedopi is given every three months until progression or toxicity.

“Tedopi after failure to previous [immune checkpoint inhibitor] therapy as third-line treatment has shown long-term clinical benefit and good safety profile,” researchers stated in their presentation.

“The potential benefit of Tedopi for patients who already have failed other treatments, including checkpoint inhibitors, is an encouraging step to show that Tedopi may provide a long-term clinical benefit for those suffering from this devastating cancer with a high unmet medical need,” Alexis Peyroles, chief executive officer of OSE Immunotherapeutics, said in a company press release.

Patient enrollment for the ATALANTE-1 study was temporarily put on hold in June 2017 over concerns about the risk-benefit of the treatment. Under a revised protocol agreed to among independent boards overseeing the trial, enrollment has resumed, but NSCLC patients who had a poor response to prior chemotherapy will no longer be recruited.