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Actionable news in CLVS: Clovis Oncology, Inc.,

Clovis Oncology, Inc. - Ir

The following excerpt is from the company's SEC filing.

Good morning. You should have received a news release announcing our rociletinib regulatory update. If not, it is available on our website,

As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available in our archive for the next several weeks.

The agenda for todays call is as follows: Patrick Mahaffy, Cloviss President and CEO, will discuss the results of our mid-cycle communication meeting with the FDA, and then we will open up the call for Q&A, for which Dr. Lindsey Rolfe, our Chief M edical Officer, will also be available.

Before we begin, please note that during todays conference call, we may make forward-looking statements within the meaning of federal securities laws, including statements concerning our financial outlook and expected business plan. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made and Clovis undertakes no obligation to update or revise any forward-looking statements. Now I will turn the call over to Patrick.

Patrick Mahaffy -

Clovis Oncology, Inc. - President, CEO & Director

Thanks, Breanna. Good morning, everybody. This morning we announced that during our preplanned scheduled mid-cycle communication meeting held last week with the FDA, the agency requested additional clinical data for use in the efficacy analysis for both the 500 milligram and 625 milligram b.i.d. dose patient groups for rociletinib.

Weve prepared this information and will provide it in a major amendment to the FDA by the close of business today. We remain of course confident in rociletinib and its potential to treat patients with mutant EGFR T790M positive lung cancer and we will continue to work diligently with the FDA on our NDA submission.

In the mid-cycle communication meeting, the FDA emphasized that its efficacy analysis would focus solely on confirmed responses. The NDA submission contained immature data sets based on both unconfirmed response rates and confirmed response rates. These data sets were updated in the 90-day efficacy update we submitted to the FDA at the end of October.

As rociletinib clinical trials were rapidly enrolling, we presented interim data publicly and at medical meetings and these data therefore included a data set based primarily on unconfirmed responses. This was also true of our breakthrough therapy destination submission and our NDA submission; both immature confirmed and unconfirmed response analyses were submitted.

As the efficacy data had matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected. In the intent-to-treat analysis of the 79 patients in the 500 milligrams dose group, the current confirmed response rate is 28% and in the 170 patients in the 625 milligram dose group, its 34%. In both cases we have a duration of response of nine months.

The most frequent reasons that patients responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30%. The majority of these patients stayed on...