Saturday, November 29, 2014 7:51:48 AM
Boehringer Ingelheim's nintedanib has become the first drug in more than 10 years to improve survival in lung cancer patients whose disease had progressed despite chemotherapy.
The results of the LUME-Lung 1 trial, presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago, showed that the drug extended survival by 2.3 months compared to placebo when added to docetaxel therapy in non-small cell lung cancer (NSCLC) patients with adenocarcinomas.
The orally-active drug was unable to improve overall survival for the entire NSCLC patient population enrolled into the study, which also included patients with squamous-type tumours, although there was a trend towards a benefit.
The primary clinical measure in the study was progression-free survival (PFS), and on this endpoint the combination of nintedanib and docetaxel had a modest effect, delaying progression by three weeks compared to docetaxel and placebo, which was a statistically significant difference.
The effect on PFS was seen in both squamous and adeno NSCLC patients, but the effect was much stronger in the latter group with an improvement compared to placebo of 1.2 months.
Nintedanib is an investigational triple angiokinase inhibitor that targets three of the receptor tyrosine kinases (FGFR, PDGFR, and VEGFR) involved in the formation of new blood vessels (angiogenesis) in tumour tissue.
"This is the first time an anti-angiogenic treatment has shown a real benefit for NSCLC patients after initial chemotherapy has failed," commented Martin Reck of the Lung Clinic Grosshansdorf in Germany, who was the principal investigator in the trial and presented the data at ASCO.
Adenocarcinoma is the most common form of NSCLC – accounting for around 40 per cent of cases – while squamous cell carcinomas make up 25 to 30 per cent, according to the American Cancer Society. Other types include large cell carcinoma (10 to 15 per cent of NSCLC cases) and rarer forms such as adenosquamous carcinoma and sarcomatoid carcinoma.
Meanwhile, a combination study looking at nintedanib in combination with Lilly's Alimta (pemetrexed) in non-squamous NSCLC, called LUME-Lung 2, was also presented as a poster at ASCO.
This trial was stopped prematurely after an interim analysis suggested no benefit. However, after it was unblinded the data showed that the combination had in fact met the primary objective of improving PFS compared to Alimta alone when given second-line after chemotherapy failure.
Nintedanib also is in phase III testing for ovarian cancer and idiopathic pulmonary fibrosis (IPF), and is in earlier-stage clinical testing for liver, kidney and colorectal cancer.
It is one of one of three cancer drugs Boehringer is ushering through clinical development after it entered the cancer area in 2006. The others are ErbB inhibitor afatinib, which has already been filed for approval in NSCLC, and polo-like kinase 1 (Plk1) inhibitor volasertib, which is being developed to treat acute myeloid leukaemia.
http://www.pmlive.com/pharma_news/asco_boehringers_nintedanib_boosts_survival_in_lung_cancer_subset_481394
Recent CDMO News
- Avid Bioservices to Participate in Craig-Hallum Bioprocessing Conference • GlobeNewswire Inc. • 09/12/2024 08:05:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 09/09/2024 08:43:56 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/09/2024 08:19:30 PM
- Avid Bioservices Reports Financial Results for First Quarter Ended July 31, 2024 • GlobeNewswire Inc. • 09/09/2024 08:05:31 PM
- U.S. Futures Rise Amid Inflation Report Anticipation; Oil Prices Climb on Hurricane Threat and Supply Concerns • IH Market News • 09/09/2024 10:09:14 AM
- Avid Bioservices to Report Financial Results for First Quarter of Fiscal Year 2025 After Market Close on September 9, 2024 • GlobeNewswire Inc. • 09/03/2024 08:05:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/29/2024 08:30:10 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 08/28/2024 08:34:04 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/28/2024 08:32:18 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/28/2024 08:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:50:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:48:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/15/2024 08:40:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 08:30:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:02:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:02:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:01:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:01:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:00:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:00:45 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/11/2024 12:23:26 AM
- Avid Bioservices Reports Financial Results for Fourth Quarter and Fiscal Year Ended April 30, 2024 • GlobeNewswire Inc. • 07/02/2024 08:05:04 PM
- Avid Bioservices to Report Financial Results for Quarter and Fiscal Year Ended April 30, 2024, After Market Close on July 2, 2024 • GlobeNewswire Inc. • 07/01/2024 11:00:21 AM
- Avid Bioservices Earns Committed Badge from EcoVadis for Sustainability Performance • GlobeNewswire Inc. • 05/23/2024 12:05:46 PM
- Avid Bioservices to Participate at Upcoming Investor Conferences • GlobeNewswire Inc. • 05/07/2024 08:05:11 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM