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the randomized phase 3 study of nivolumab

versus bevacizumab in recurrent glioblas-

toma. That was presented at the World

Federation of Neuro-Oncology Societies

just a few months ago, and unfortunately

that trial was negative. There was no differ-

ence in outcome between nivolumab and

bevacizumab in recurrent glioblastoma. But

what they did in this trial was they looked at

those patients who appear to be progress-

ing and had surgery to see if they could

look at the pathology to differentiate those

patients who are truly progressing and

those patients who may have what’s called

pseudo-progression or an inflammatory

response. They actually didn’t see a lot of

inflammation in these tumors and the patho-

logic analysis did not really predict outcome.

So that’s an area that we still need to do a

lot of work on separating pseudo-progres-

sion from true tumor progression.

Dr Caudle:

You mentioned briefly the con-

cept of timing, especially for immune

therapies, and I want to talk a little bit about

that. When during therapy do you think is

the optimal timing for the integration of

immune therapies, particularly given the

immune suppression inherent in standard

adjuvant therapy?

Dr Wen:

I think initially a lot of the trials were

done in recurrent disease so this follows

radiation therapy and temozolomide, both

of which can produce a fairly profound lym-

phopenia. And then the tumors are often

bulky when patients are on steroids. So in

that setting, trying to stimulate the immune

system is probably a real challenge.

I think many of the newer studies are in

first-line setting in patients who’ve had a

gross total resection. There isn’t a lot of

residual disease that can produce immu-

nosuppressive factors and where the

patient’s immune system is more robust

because they’ve just started their treat-

ment with radiation or temozolomide. And

in some of these patients and those who

are MGMT-unmethylated, which temozolo-

mide is not particularly useful, there’s been

a trend to drop the temozolomide so these

patients would get just the radiation and

whatever immunotherapeutic agent is being

planned with the hopes that by avoiding the

temozolomide, the immune suppression will

be avoided also. Those studies are ongoing.

Dr Caudle:

Let’s switch gears just a little bit.

Can you elaborate on the recent study that

was evaluating the use of a personalized

peptide vaccine in patients with refractory

GBMs and how this new class of agents can

potentially move up to the upfront setting?

Dr Wen:

Yes. So they used peptide vaccines

and tried to match it to the patient’s geno-

type. In fact, there are a number of these

studies now ongoing in the first-line set-

ting both in Europe and then in the US. At

Dana-Farber, my colleague David Reardon

is running one of these trials for the vaccine

called NeoVax where patients get whole-ex-

ome sequencing and then, depending on

the mutations, a personalized vaccine is

made for that patient. It’s administered to

the patient after radiation and temozolomide

with the plan to add a PD-1 antibody to that

regimen. I think that these approaches are

really exciting and there’s more and more

of these being developed.

Jennifer Caudle DO is

Assistant Professor at Rowan

University School of

Osteopathic Medicine in

New Jersey.

Watch the full interview on

PracticeUpdate.com

FROM 1

ST

FEBRUARY 2017

PBS Information:

Lynparza. Authority Required. For maintenance treatment of germline BRCA mutated platinum-sensitive

relapsed high-grade serous ovarian, fallopian tube or primary peritoneal cancer for patients who have responded to prior

platinum based chemotherapy. Refer to PBS schedule for full authority information.

BEFORE PRESCRIBING, PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON REQUEST

FROM ASTRAZENECA ON 1800 805 342 OR

www.astrazeneca.com.au/PI

LYNPARZA

®

(

olaparib

)

Minimum Product Information:

INDICATIONS:

Monotherapy for the maintenance treatment of patients with platinum - sensitive relapsed

BRCA

- mutated

(

germline or

somatic

)

high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response

(

complete response or partial response

)

after platinum - based chemotherapy. Prior

treatment must have included at least 2 courses of platinum - based regimens.

CONTRAINDICATIONS:

Hypersensitivity to the active substance

(

olaparib

)

or to any of the excipients.

PRECAUTIONS:

Haematological toxicity

is common in patients treated with olaparib and usually mild - moderate. Patients should not start treatment with LYNPARZA until they have recovered from haematological

toxicity caused by previous anti - cancer therapy. A baseline complete blood count followed by monthly monitoring is recommended for the first 12 months of treatment and periodically after this.

Myelodysplastic syndrome/Acute Myeloid Leukaemia

(

MDS/AML

)

have been reported in a small number of patients

(

<1%

)

and the majority of reports have been fatal.

Pneumonitis

has been reported

in a small number of patients receiving olaparib, and some reports have been fatal.

Use in pregnancy:

Category D. LYNPARZA may cause foetal harm when administered to a pregnant woman. Women

of child bearing potential must use effective contraception during treatment and for 1 month after receiving the last dose.

Use during lactation:

Breast feeding should be avoided in women receiving

LYNPARZA and for 1 month after the last dose.

Use in Men:

Not indicated Children or adolescents: Not indicated.

Interactions with other medicines.

INTERACTIONS:

LYNPARZA co administration with

strong CYP3A inducers or inhibitors should be avoided. Addition of LYNPARZA and cytotoxic agents has been shown to potentiate and prolong myelosuppressive side effects.

ADVERSE REACTIONS

:

Very common

(

≥10%

)

:

decreased appetite, headache, dysgeusia, dizziness, nausea, vomiting, diarrhoea, dyspepsia, fatigue, anaemia, neutropenia, lymphopenia, mean corpuscular volume elevation,

increased creatinine;

Common

(

≥1% to <10%

)

:

stomatitis, upper abdominal pain, thromboyctopenia; for other listed adverse reactions, see full PI.

DOSAGE AND ADMINISTRATION:

400 mg

(

eight

50 mg capsules

)

taken twice daily, equivalent to a total daily dose of 800 mg. LYNPARZA should be taken on an empty stomach and patients should refrain from eating for 2 hours.

Date of first

inclusion in the ARTG:

7th January 2016.

References 1.

Lynparza Approved Product Information 10 October 2016.

2.

PBS Website

http://www.pbs.gov.au/pbs/home

[Accessed 1 February, 2017]. Lynparza

TM

is a trademark of the AstraZeneca group of companies. AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie

Park, NSW 2113. AstraZeneca Medical Information: 1800 805 342.

www.astrazeneca.com.au

. AU-2176, WL294703, February 2017.

Explanatory note:

Patients who are found to have a germline BRCA1 or

BRCA2 mutation should be referred for post-test genetic counselling, as

there may be implications for other family members. Appropriate genetic

counselling should be provided to the patient either by the specialist treating

practitioner, a genetic counselling service or a clinical geneticist on referral.

MBS item 73295:

Detection of germline BRCA1 or BRCA2 gene mutations, in a patient with platinum-sensitive

relapsed ovarian, fallopian tube or primary peritoneal cancer with high grade serous features or a high grade serous

component, and who has responded to subsequent platinum-based chemotherapy, requested by a specialist or

consultant physician, to determine whether the eligibility criteria for olaparib under the Pharmaceutical Benefits

Scheme

(

PBS

)

are fulfilled.

ASCO 2017

19

VOL. 1 • NO. 2 • 2017