ASCO 2007: Leadership Summit on NSCLC

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ASCO 2007: Leadership Summit on NSCLC

A Panel Discussion among Oncologists

June 2007

study description and objectives

To review information presented at ASCO 2007 and discuss up-to-date treatment practices for non-small cell lung cancer (NSCLC).

Survey choices for first-, second-, and third-line therapy for MM including the use of:

Bevacizumab (Genentech’s Avastin®)
Erolotinib (Genentech’s Tarceva®)
Cetuximab (ImClone’s Erbitux®)

Review specific considerations in the prescription of each of the above drugs including dosing and side effects
Examine the latest data presented at ASCO including:

The AVAiL trial examing the use of Avastin
Treatment potential of Erbitux
Treatment potential of sunitinib (Pfizer’s Sutent®) and sorafenib (Bayer’s Nexavar®)
Treatment potential of axitinib (AG-013736)

Explore new pharmaceutical agents under development to treat NSCLC

companies and Products mentioned in this report

Company	Ticker Symbol	Product(s)
Genentech	DNA	Avastin® (bevacizumab) Tarceva® (erolotinib)
OSI Pharmaceuticals	OSIP	Tarceva® (erolotinib)
Eli Lilly	LLY	Alimta®, (pemetrexed)
ImClone Systems Incorporated	IMCL	Erbitux® (cetuximab)
Bristol-Myers Squibb	BMY	Erbitux® (cetuximab)
Merck	MRK	Erbitux® (cetuximab)
Pfizer	PFE	Sutent® (sunitinib) Axitinib (AG-013736)
Bayer		Nexavar® (sorafenib)

Key Findings

First-line therapy for NSCLC. Avastin – Avastin is used as first-line therapy in an average of 36% of patients. Patient eligibility is generally determined by ECOG 4599 criteria, and it is not used in patients who have a history of hemoptysis, untreated brain metastases, bleeding disorders or a squamous cell histologic subtype. Tarceva – Tarceva is used as first-line therapy in an average of 6% of patients. Potential patient eligibility characteristics include non-smokers, females, poor performance status, bronchoalveolar carcinoma or adenocarcinoma histologies, advanced age, Asian ethnicity, and poor candidacy for chemotherapy.

Second-line therapy for NSCLC. Avastin – Avastin is used as second-line therapy in an average of 11% of patients. It is usually given to patients who did not receive it as part of first-line therapy. Avastin is sometimes continued as maintenance therapy after first-line or second-line treatment with it, although there is no data to support or refute this practice. Tarceva – Tarceva is used as second-line therapy in an average of 34% of patients. Patient eligibility characteristics are similar to those used to determine eligibility for Tarceva as first-line therapy. It is often superceded by Eli Lilly’s Alimta® (pemetrexed) as second-line therapy. Avastin and Tarceva – A trial is underway to determine the safety and efficacy of this combination therapy. Some physicians won’t use it while others note “widespread” use.

Third-line therapy for NSCLC. Avastin – No one reported using Avastin as a single agent as third-line therapy. Tarceva – Tarceva is used as a single agent for third-line therapy in 34% of patients. Other choices include Alimta and Sanofi-Aventis’ Taxotere® (docetaxel).

Dosing trends. Avastin – 7/9 panelists are still using the 15 mg/kg dosing every three weeks; of these, 3 are considering changing to the 7.5 mg/kg dosing. Tarceva – All panelists start with 150mg daily to start, but approximate 20% of patients require a decrease in dose to 100mg due to side effects.

The AVAiL trial. 5/7 panelists report using the 15 mg/kg dose while 2/7 panelists stated they changed to 7.5 mg/kg dosing. All five panelists mentioned wating to see overall survival data before changing their dosing regimens. Some noted that they won’t change their practice because they use taxane-based doublets.

Other agents. Erbitux – Should be considered for phase 3 study in NSCLC; may have potential use in patients who are not candidates for Avastin. Sutent and Nexavar – It is unclear if one agent is more promising than another; may be best introduced in combination with standard agents; both require further study. Axitinib – It is too early to tell much about this drug.

inclusion criteria

Inclusion Criteria

Key opinion leaders in the field of oncology who specialize in the treatment of non-small cell lung cancer (NSCLC)

Panelists and demographics

Physician	Hospital/Academic Affiliation	Location
Kenneth Algazy, MD	University of Pennsylvania	PA
William Blackstock, MD	Wake Forest University	NC
Roger Cohen, MD	Fox Chase Cancer Center	PA
Salvatore Del Prete, MD	Bennett Cancer Center	CT
John Hainworth, MD	Sarah Cannon Research Institute	TN
Kenneth Ng, MD	Memorial Sloan Kettering Cancer Center	NY
Gregory Otterson, MD	Ohio State University	OH
Pieter Postmus, MD	Vrije Universiteit Medical Centre	Amsterdam, Netherlands
Francisco Robert, MD	University of Alabama at Birmingham	AL
Heather Wakelee, MD	Stanford University	CA

Primary Question Index

Question	Page
Q1: First-line therapy with Avastin In what percent of non-squamous cell NSCLC patients do you use Avastin? How frequently do you use Avastin as first-line therapy in other off label histologies, and what criteria do you use to determine if its use is warranted?	9
Q2: First-line therapy with Tarceva Do you use Tarceva in the first-line setting? If so, what percent of your patients receive Tarceva as first-line therapy? Please describe the “typical” patient who receives Tarceva as first-line treatment. Why do you choose it over other agents in these patients?	11
Q3: Second-line therapy with Avastin In what percent of non-squamous cell NSCLC patients do you use Avastin as second-line therapy? Please describe a “typical” patient who receives Avastin as second-line therapy. What factors play in to your decision of whether or not to use it as second-line therapy? Do you ever continue Avastin from first-line therapy into second-line therapy and alter the chemotherapy backbone?	12
Q4: Second-line therapy with Tarceva Do you use Tarceva in the second-line setting? If so, what percent of your patients receive Tarceva as second-line therapy? Please describe the “typical” patient who receives Tarceva as second-line treatment. Why do you choose it over other agents?	15
Q5: Combination second-line therapy Do you use a combination of Tarceva and Avastin in the second-line setting? If so, please describe the “typical” patient who receives these therapies. What percent of your patients receive Tarceva and Avastin together as second-line therapy? Why do you choose to use this combination?	17
Q6: Third-line therapy for NSCLC For each of the following regimens, please describe the percent of your patients receiving the third-line therapy, and the “typical” patient who receives it: Avastin; Tarceva; and Avastin plus Tarceva.	19
Q7: Overall Dosing Trends What is the most common dose of Avastin in the first-line setting? What percent of first-line patients have received a lower Avastin dose (7.5 mg/kg)? What is the average dose of Tarceva in the first-line, second-line, and third-line settings?	20
Q8: Medication toxicities What percent of your patients taking Avastin for any line of therapy discontinue the medication due to adverse events? In your view, what is the most important safety signal(s) with Avastin? What percent of your patients taking Tarceva for any line of therapy discontinue the medication due to adverse events? In your view, what is the most important safety signal(s) with Tarceva?	21
Q9: The AVAiL trial Please review the attached ASCO 2007 abstract about bevacizumab and the AVAiL trial. How do you expect this data to impact your clinical practice? Please discuss the relevance of the AVAiL study given the use of the European chemo regimen (gem/cis). What are your thoughts on the lower-than-expected PFS benefit for both dose groups? Would you lower your dose of Avastin based on this trial and why? If Avastin showed an overall survival benefit in the low-dose arm (7.5 mg/kg) but not the high-dose arm (15 mg/kg), how would that change your dosing patterns?	22
Q10: Erbitux Please review the attached ASCO 2007 abstracts on Erbitux in NSCLC. Do you believe that Erbitux has a place in the treatment of NSCLC and if so, why? Based on the abstracts above and your knowledge of clinical trials in NSCLC, please discuss the potential of success for Erbitux in the Phase III setting.	25
Q11: Sutent and Nexavar Please review the attached ASCO 2007 abstracts on sunitinib (Pfizer’s Sutent®) and sorafenib (Bayer’s Nexavar®). Do you believe that Sutent and Nexavar are viable additions to the NSCLC armamentarium? Which agent do believe holds more promise and why? What are the risks associated with these agents?	26
Q12: Axitinib Please review the attached ASCO 2007 abstract about axitinib (AG-013736). Do you believe that axitinib is a potentially viable addition to the NSCLC armamentarium? How does it compare to Sutent or Nexavar?	27
Q13: Prospective agents In your view, what are the most promising agents currently in phase II and phase III trials? What is your opinion on the use of immunotherapy in NSCLC, specifically on PF3512676 (aka Promune or CPG7909)?	28
Appendices A - D	30

ASCO 2007: Leadership Summit on NSCLC

Discussion Transcript

Introduction

Welcome to this discussion among oncologists in which we will review information presented at ASCO 2007 and discuss up-to-date treatment practices for non-small cell lung cancer (NSCLC). We will also ask you to comment on specific agents including bevacizumab (Genentech’s Avastin®), erlotinib (Genentech’s Tarceva®), and cetuximab (ImClone’s Erbitux®). MedPanel discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. Please note: In your participation on this panel, Panel Intelligence expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your Panel Intelligence home page after you've logged in.

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Instant survey please complete.

Instant Survey

How many patients with NSCLC do you see per month?

50
20
52
30
8
60
200
20
new- 20-30, returns 120-150
New: 15-16

% Squamous cell

30
15
5
35
20
30
20
40
5
30

% Non-squamous cell

70
85
0
45
80
50
20
20
95
70

% Adenocardinoma

50
70
90
15
50
50
60
35
75
40

% Other

0
0
5
5
0
20
0
5
20
30 (NOS)

Instant survey please complete.

Instant Survey

What regimen do you use most frequently as first-line therapy for each of the histologies of NSCLC including squamous cell, non-squamous cell, and adenocarcinoma?

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