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Phase 3 Data Show Celltrion’s Bevacizumab Biosimilar Is Equivalent to Avastin in Lung Cancer

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If approved, Celltrion's CT-P16 would be the fourth bevacizumab biosimilar to reach the market.

The summary of this story was edited after publishing to reflect that the Celltrion product would be the fourth bevacizumab biosimilar to reach the US market, after the FDA approval of bevacizumab-maly from Amneal Pharmaceuticals.

New phase 3 data show Celltrion’s proposed biosimilar of bevacizumab produced an objective response rate (ORR) equivalent to the reference product Avastin in patients with metastatic or recurrent non-small cell lung cancer (NSCLC). The study was presented Friday during the American Association of Cancer Research (AACR) annual meeting in New Orleans, Louisiana.

Based on these results, Celltrion has completed applications for the product, known as CT-P16, in the United States, the European Union, and Korea, for all of Avastin’s indications, according to a statement released to media in Asia after The Center for Biosimilars® asked for comment on the results.

“As CT-P16 proved similar in safety to the original drug in phase 3 large-scale global clinical trials, we plan to speed up the approval process through consultation with regulatory authorities in each country," the statement said. “We will do our best to ensure the prompt supply of high-quality anticancer antibody biosimilars when we obtain approval from each country.”

Celltrion officials announced the phase 3 study back in 2019, following positive phase 1 results for their bevacizumab biosimilar. At that time, competitors for Avastin had not reached the market. Since then, Amgen’s Mvasi and Pfizer’s Zirabev have been approved for indications that include metastatic or recurrent NSCLC. Another biosimilar from Boehringer-Ingelheim is no longer under development. Celltrion, however, has said previously that the company plans to compete with other biosimilars on price.

The double-blind, randomized, multicenter study compared CT-P16, the investigational biosimilar, with the FDA-approved version of bevacizumab; both were used in combination with carboplatin and paclitaxel up to 6 cycles (induction period), followed by maintenance CT-P16 or bevacizumab monotherapy until patients experienced disease progression or unacceptable toxicity.

The study’s primary end point was ORR during the induction period; this was defined as complete or partial responses using RECIST v1.1 as assessed by an independent reviewer. Secondary end points were quality of life (QOL), pharmacokinetics (PK), safety, and immunogenicity.

Investigators randomized a total of 689 patients, with 342 receiving the biosimilar and 347 receiving bevacizumab. According to the AACR abstract, baseline characteristics were well balanced. Results were similar between the 2 treatment arms:

  • In the intent-to-treat (ITT) group, the investigator reviewed ORR was 42.40 (37.16-47.64) for the biosimilar and 42.07 (36.88-47.27) for bevacizumab); in the per-protocol (PP) group, the ORR was 45.28 (39.81-50.75) for the biosimilar (318 patients) and 47.19 (41.57-52.82) for bevacizumab (303 patients).
  • The 90% confidence intervals for the risk ratio estimate (0.7368, 1.3572) and 95% Cis for risk difference estimate (±12.5%) were within the equivalence margin for both ITT and PP sets.
  • Investigators reported that PK and QOL results were comparable between the 2 groups.
  • Overall incidence of treatment-emergent adverse events (TEAEs), serious AEs, AEs leading to discontinuation, and AEs leading to death was similar between the 2 arms: TEAEs, 96.2% vs 92.4%; 19.4% vs 20.1%; 15.1% vs 14.5%, and 6.4% vs 6.4%, for the CT-P16 and bevacizumab arm, respectively.
  • Incidence of treatment-emergent drug antibodies was comparable, 14.2% vs 16.0%.

“This study demonstrated that CT-P16 is equivalent to [Avastin] as measured by ORR in patients with metastatic or recurrent adenocarcinoma of the lung,” the authors wrote.

Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.

Reference

Ohe Y, Bondarenko I, Andric Z, et al. Randomized phase III study comparing the efficacy and safety of CT-P16, a new biosimilar, to reference bevacizumab (Avastin), in patients with metastatic or recurrent non-small cell lung cancer (NSCLC). Presented at: the American Association of Cancer Research Annual Meeting; April 8-13, 2022; New Orleans, LA; Abstract CT551. https://www.abstractsonline.com/pp8/#!/10517/presentation/20290


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