Oraxol by Hanmi apply US license

Athenex, phases III of Oraxol opened at international conference,

Effectiveness goal achievement, Highlighted some safety issues, including gastrointestinal adverse events

The commercialization of the anti-cancer drug 'Oraxol', a technology exported by Hanmi, is imminent.

 

Hanmi's US partner Athenex unveiled its Phase III clinical results for patients with metastatic breast cancer and announced its intention to approve the FDA in early next year.

 

Some assessments suggest that some indicators, such as gastrointestinal adverse events, do not meet expectations.

 

◆Athenex, confirmation of anticancer effect of Phase III clinical trial for oral Paclitaxel

Athenex unveiled the results of its Phase III clinical study at the San Antonio Breast Cancer Symposium (SABCS 2019) held in Texas, USA on 13th (local time).

 

This study compares the efficacy and safety of randomly assigned metastatic breast cancer patients enrolled in 45 Latin American clinical trials into Oraxol group or Paclitaxel IV group.

 

Oral test drug 205 mg / m² three times a week, and the control group received 175 mg / m² of Paclitaxel intravenous injection every three weeks, and then confirmed the tumor response through imaging tests.

 

The conference announcement was similar to the topline results that Athenex released in August.

 

According to the Intention to Analyze (ITT), which included those who discontinued or changed the treatment during the clinical trial, the objective response rate (ORR) of the Oraxol group was 35.8% (95 of 265) better tumor suppression effect (P = 0.001) than 23.4% (32 of 137) of the IV group.

 

The median response time was higher in the Oraxol group (27.9 months) than in the Paclitaxel intravenous group (16.9 months), overall survival (median) was also significantly different (P = 0.035) at 27.9 months and 16.9 months respectively.

 

However, the progression-free survival period (median value) was 9.3 months in the group taking Oraxol, which did not show a statistically significant difference from the IV group (8.3 months) (P = 0.077).

 

Oraxol, Phase III Clinical Results (Source: Athenex)

'Oraxol' is a synthetic drug that Hanmi exported to Athenex in the US in 2011.

 

Hanmi Pharmaceutical turned its Paclitaxel injection into oral by applying its own developed ORASCOVERY platform technology.

 

By blocking the membrane transport protein P-glycoprotein (P-gp) that interferes with the oral absorption of anticancer drugs, it is a mechanism to improve the absorption rate has been pointed out as a disadvantage of oral drugs.

 

The Paclitaxel injection, which is the most commonly used for breast cancer treatment, is changed to oral drug, thereby increasing convenience and increasing marketability.

 

It is also meaningful that Hanmi’s ORASCOVERY platform technology has entered commercialization on track.

 

◆Investment industry, "Effective goal met, but adverse reaction is key" However, the investment industry is disappointing with the results of the Phase III clinical trials.

 

Although the primary efficacy endpoints were met, the safety profile was ambiguous.

 

Shortly after the conference, Athenex shares fell 17 percent.

 

According to the report, the incidence of alopecia and severe neuropathy adverse events was 17% in the Oraxol group, which was lower than 57% in the intravenous group.

 

Severe neuropathy symptoms were also improved in the Oraxol group at 1% and 8%.

 

Toxicity profile was similar.

 

On the other hand, neutropenia, infection, and gastrointestinal adverse events were higher in the Oraxol group.

 

Athenex

Based on this three-phase clinical data, Athenex expresses its intention to commercialize the Oraxol in earnest, and the marketability of the Oraxol is expected to be tested.

 

Atenex executives said during the third quarter of last month's results that they are preparing a pre-meeting to submit a new drug application (NDA) for the US Food and Drug Administration (FDA) in the first quarter of next year.

 

He also said he is also considering expanding the range of Oraxol’s use to other carcinomas, including advanced gastric cancer, using anti-PD-1 antibodies such as Keytruda.

 

In addition to Paclitaxel, the company aims to develop oral formulations of various anticancer drugs such as Irinotecan and Eribulin using ORASCOVERY Platform technology.

 

Athenex executives held the conference call related to the announcement of SABCS 2019.

 

He stressed “Oraxol has achieved meaningful results in phase III clinical trials, and this is the first case of Paclitaxel that has been converted to oral to demonstrate anti-cancer effects, and Oraxol is expected to be an important treatment option for breast cancer patients”.