Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced that results from an ongoing Phase II clinical
trial of Puma's drug neratinib are being presented at the 2018 San
Antonio Breast Cancer Symposium (SABCS) that is currently taking
place in San Antonio, Texas. The presentation entitled, “Neratinib
+ fulvestrant for HER2-mutant, HR-positive, metastatic breast
cancer: Updated results from the phase 2 SUMMIT trial,” are being
presented at a Spotlight Session by Lillian M. Smyth, M.D., Breast
Medicine Service and Early Drug Development Service, Memorial Sloan
Kettering Cancer Center, an investigator of the trial.
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Neratinib was approved by the U.S. Food and Drug Administration
(FDA) in July 2017 for the extended adjuvant treatment of adult
patients with early stage HER2-positive breast cancer following
adjuvant trastuzumab-based therapy, and is marketed in the United
States as NERLYNX® (neratinib) tablets. NERLYNX was granted
marketing authorization by the European Commission for the extended
adjuvant treatment of hormone receptor-positive HER2-positive early
stage breast cancer in September 2018.
The Phase II SUMMIT basket trial is an open-label, multicenter,
multinational study to evaluate the safety and efficacy of
neratinib administered daily to patients who have solid tumors with
activating HER2 or HER3 mutations. In the HER2-mutant, HR-positive
breast cancer cohort, 47 patients received 240 mg of neratinib
daily in combination with fulvestrant at the labeled dose. In this
cohort, 43 patients (92%) had HER2-non-amplified disease, and
patients had received a median of 3 prior lines of therapy in the
metastatic setting (range 0-11 prior regimens) before entering the
trial. All patients had been previously treated with an endocrine
agent prior to entering the study, including 25 patients (53%) who
had received prior fulvestrant. Further, 20 patients (43%) received
prior cyclin-dependent kinase 4/6 (CDK4/6)-inhibitor therapy.
The efficacy summary of the breast cohort that received
neratinib + fulvestrant is shown in Table 1 below. The interim
efficacy results from the trial showed that for the 47 efficacy
evaluable patients, 14 patients (30%) experienced an objective
response, which included 4 patients with a complete response and 10
patients with partial responses, and 22 patients (47%) experienced
clinical benefit (clinical benefit is defined as confirmed complete
response or partial response or stable disease for at least 24
weeks). The median duration of response was 9.2 months and the
median progression free survival was 5.4 months. Subgroup analysis
demonstrated that patients who had received prior fulvestrant or
CDK4/6 inhibitor targeted therapy prior to entering the trial also
benefited from treatment of neratinib + fulvestrant. Of note, 6
patients (30%) with prior CDK4/6-inhibitor exposure demonstrated
confirmed responses, with the duration of responses ranging from
4.5–14.8 months. Four patients were still on treatment at the time
of data reporting.
Table 1: HER2-Mutant, HR-Positive Metastatic Breast Cancer
Phase II SUMMIT Trial Efficacy Summary
Neratinib + Fulvestrant Subgroups
All Patients(n=47)
Prior Fulvestrant(n=25)
Prior CDK4/6
Inhibitor-BasedTherapy (n=20)
Efficacy Endpointa: Objective response
(confirmed)b – n 14 4 6 CR 4 0 1 PR 10 4 5 Objective response rate
(95% CI)
30 (17–45)
16 (5–36)
30 (12–54)
Medianc DOR, months (95% CI)
9.2 (5.5–16.6) DOR for each
responder 9.2; 9.3*; 14.8*; 16.6 4.5; 7.3; 9.2*; 9.3*; 11.2*; 14.8*
Clinical benefitd – n 22 9 8 CR or PR 14 4 6 SD 8 5 2
Clinical benefit rate (95% CI)
47 (32–62)
36 (18–58)
40 (19–64) Medianc PFS (95% CI) time to event, months
5.4 (3.7–9.2)
3.7 (3.5–6.9)
4.1 (1.9–10.9)
Patients with RECIST v1.1 Measurable Disease
Subgroups Efficacy Endpointa: All
Patients
(n = 39)
Prior Fulvestrant
(n = 21)
Prior CDK4/6
Inhibitor-BasedTherapy (n=15)
Objective response (confirmed)b – n 12 4 5 CR 2 0 0 PR 10 4 5
Objective response rate (95% CI)
31 (17–48)
19 (5–42)
33 (12–62) Medianc DOR, months (95% CI)
9.0
(4.5–16.6) DOR for each responder 9.2; 9.3*; 14.8*; 16.6 4.5; 7.3;
9.2*; 9.3*; 14.8* Clinical benefitd – n 18 8 6 CR or PR 12 4
5 SD 6 4 1 Clinical benefit rate (95% CI)
46 (30–63)
38 (18–62)
40 (16–68) Medianc PFS (95% CI) time to
event, months
5.4 (3.5–10.3) NA NA
a
Response is based on investigator tumor
assessments per RECIST v1.1 or modified PERCIST for patients with
only PET-evaluable lesions.
b
Overall objective response (ORR) is
defined as either a complete or partial response that is confirmed
no less than 4-weeks after the criteria for response are initially
met.
c
Kaplan-Meier analysis
d
Clinical benefit rate (CBR) is defined as
confirmed CR or PR or stable disease (SD) for at least 24 weeks
(within +/- 7 day visit window).
*
Patient still on treatment at time of data
cut; DOR, duration of response; PFS, progression free survival; NA,
not available
The safety profile observed in neratinib + fulvestrant-treated
breast cancer patients in the SUMMIT study was consistent with that
observed previously in metastatic patients with HER2 amplified
tumors. With anti-diarrheal prophylaxis and management, diarrhea
was not a treatment-limiting side effect in SUMMIT. The interim
safety results of the study showed that the most frequently
observed adverse event was diarrhea. For the 47 patients enrolled
in the trial, 11 patients (23%) reported grade 3 diarrhea. The
median duration of grade 3 diarrhea for those patients was 1.5
days. No patients permanently discontinued neratinib due to
diarrhea.
Dr. Lillian Smyth said, “Somatic HER2 mutations represent a
distinct class of oncogenic driver mutations that appear to be
clinically actionable for metastatic breast cancers. The
combination of neratinib plus fulvestrant therapy demonstrates
encouraging clinical activity with durable responses in this
heavily pretreated metastatic breast cancer patient population with
HER2-mutated and hormone receptor-positive disease.”
Alan H. Auerbach, CEO and President of Puma Biotechnology,
added, “We are very pleased with the updated activity seen with
neratinib in combination with fulvestrant in this cohort of
patients with HER2-mutated breast cancer. We look forward to the
further development of the combination of neratinib and fulvestrant
in this patient population.”
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a
focus on the development and commercialization of innovative
products to enhance cancer care. Puma in-licenses the global
development and commercialization rights to three drug candidates —
PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
Neratinib, oral was approved by the U.S. Food and Drug
Administration in July 2017 for the extended adjuvant treatment of
adult patients with early stage HER2-overexpressed/amplified breast
cancer, following adjuvant trastuzumab-based therapy, and is
marketed in the United States as NERLYNX® (neratinib) tablets.
NERLYNX was granted marketing authorization by the European
Commission for the extended adjuvant treatment of hormone
receptor-positive HER2-positive early stage breast cancer in
September 2018. NERLYNX is a registered trademark of Puma
Biotechnology, Inc.
Further information about Puma Biotechnology may be found at
www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the development of combinations
involving neratinib. All forward-looking statements involve risks
and uncertainties that could cause Puma’s actual results to differ
materially from the anticipated results and expectations expressed
in these forward-looking statements. These statements are based on
current expectations, forecasts and assumptions, and actual
outcomes and results could differ materially from these statements
due to a number of factors, which include, but are not limited to,
the risk factors disclosed in the reports filed by Puma with the
Securities and Exchange Commission from time to time, including
Puma’s Annual Report on Form 10-K for the year ended December 31,
2017. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Puma assumes no obligation to update these forward-looking
statements, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20181206005252/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1-424-248-6500info@pumabiotechnology.comir@pumabiotechnology.com
David Schull or Alex Fudukidis, Russo Partners,
+1-212-845-4271david.schull@russopartnersllc.comalex.fudukidis@russopartnersllc.com
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