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Expert Interview

Slingshot members are talking to an expert! The topic is:

Examining Athenex's Lead Candidate, Oraxol in Metastatic breast cancer, in relation to February 28 PDUFA

Ticker(s): ATNX

Who's the expert?

An oncologist with experience in Metastatic breast cancer.

Interview Questions
Q1.

Please tell us about your experience as a physician. How many patients with metastatic breast cancer do you see on a yearly basis? What are some ways in which your approach has changed over the time?

Added By: slingshot_insights
Q2.

What can you tell us about the mechanism of action of paclitaxel as a cytoskeletal drug targeting tubulin, and in what ways is the company’s oral paclitaxel + encequidar formulation different than IV paclitaxel ?

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Q3.

  • Can you walk us through supporting evidence on the use of paclitaxel in metastatic breast cancer, considering that NICE only recommends paclitaxel for the treatment of advanced breast cancer after the failure of anthracyclic chemotherapy, saying that first-line use should be limited to clinical trials
  • How does paclitaxel compare to other treatments in the MBS space?

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Q4.

What is your impression of paclitaxel’s efficacy in MBS, considering that it is officialy not recommended in adjuvant treatment of early node-positive breast cancer?

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Q5.

Can you comment on oraxol’s median PFS of 8.4 months vs. 7.4 months IV paclitaxel, and also on median OS of 22.7 months vs. 16.5 months. How reliable do you think these findings are?

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Q6.

What is your impression of the reported grades of neuropathy standing at 22% vs. 64%, and grade 3 neuropathy at 2% vs. 15%?

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Q7.

On the topic of adverse side effects,can you tell us what you think about the reported grade 2 vomiting before and after amendment (24% vs. 7%) and grade 2 diarrhea before and after amendment (27% vs. 16%)?

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Q8.

Could you comment on the dosage arms of 205 mg/m2 of oral paclitaxel + 15 mg of encequidar) for three days a week vs IV paclitaxel regimen (175 mg/m2) as a three-hour infusion every three weeks, as it relates to the efficacy and AEs data reported?

Added By: slingshot_insights
Q9.

How likely would you be to switch patients to Oraxol, if approved?

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