Zykadia (ceritinib) by Novartis is approved for first line use in US

As of May 26, 2017 the FDA approved ceritinib for first line use. So it will go head to head with crizotinib. One article said a similar EU approval was likely “in coming weeks”.

The results are based on the phase 3 ASCEND-4 trial which found that in the first line setting that patients who took  ceritinib had a median progression-free survival of 16.6 months vs. 8.1 months on Pemetrexed platinum chemotherapy.

https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-expanded-use-zykadiar-first-line-alk-positive

 

Posted in Brain metastases, ceritinib - Zykadia from Novartis, Lung cancer, Potential Treatments, Regulatory applications & approvals, Research | Leave a comment

FDA approves brigatinib

On April 28, 2017 the FDA granted Takeda (formerly Ariad) approval for Alunbrig (brigatinib) to be sold in the US to patients who are resistant to Crizotinib.

Posted in brigatinib-Alunbrig from Takeda, Lung cancer, Potential Treatments, Regulatory applications & approvals | Leave a comment

Lorlatinib granted breakthrough therapy status

On April 27, 2017, the FDA granted Pfizer Breakthrough Status on lorlatinib for patients previously treated with one or more ALK inhibitors. So you don’t have to take Crizotinib first, any of the other 3 will do. Also a Phase 3 CROWN study (NCT03052608) has begun enrolling patients.

Posted in Brain metastases, lorlatinib - Lorbrena by Pfizer, Lung cancer, Potential Treatments, Research | Leave a comment

Clinical Trial of PLB1003 by Beijing Pearl Biotechnology

As of April 19, 2017 ClinicalTrials.gov lists a phase 1 trial of PLB1003 which targets ALK. At this time the trial is at one site: Shanghai Chest Hospital.

To qualify you must have one measurable met in the body.

The trial identifier is: NCT03130881.

Posted in Lung cancer, PLB1003 - Beijing Pearl Biotechnology, Potential Treatments, Research | Leave a comment

Clinical trial of TPX-0005 from TP Therapeutics

As of March 6, 2017, ClinicalTrials.gov lists a Trial of TPX-0005 which targets ALK, ROS1, and NTRK 1-3. At this time there are four trial sites at: UC Irvine Cancer center, University of Colorado, Denver, Massachusetts General Hospital, and Memorial Sloan Kettering.

The trial does cover patients with regular body measurable mets and only measurable brain mets.

The trial identifier is NCT03093116.

Posted in Brain metastases, Lung cancer, Potential Treatments, Research, TPX-0005: TP Therapeutics | Leave a comment

Ariad files FDA application and gets acquired

As of August 30, 2016 Arriad had filed its new drug application with the FDA for brigatinib. As of Oct 31, 2016 the FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017.

As of January 9, 2017 Ariad agreed to be bought by Takeda Pharmaceutical Company Limited, a Japanese company. The merger is expected to close by the end of February 2017.

http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-news&nyo=0

Posted in brigatinib-Alunbrig from Takeda, Lung cancer, Regulatory applications & approvals | Leave a comment

Update on Novartis and Ariad trials

As of Dec. 6, 2016 Novartis and Ariad announced research updates

In Phase III study by Novartis on Zykadia® (ceritinib) as a first-line treatment, they found a 45% reduction in the risk of disease progression. The study found a median progression free survival (PFS) of 16.6 months for all patients taking ceritinib, compared with 8.1 months for patients treated using just chemotherapy.  Also reported an ORR of 72.5%, compared with 26.7% for chemotherapy patients. Patients with no brain metastases had a median PFS of 26.3 months with Zykadia compared with 8.3 months for standard chemotherapy.

Ariad had positive info from a Phase I/II study and a pivotal phase 3 ALTA trial studying brigatinib, in patients with brain metastases.  Patients with brain mets had an ORR was 53% in the Phase I/II trial.

The patients previously treated with Crizotinib and with brain mets had an ORR of 67% in the higher dose arm B of the ALTA trial. Median brain mets PFS in Arm B was 18.4 months.

http://www.genengnews.com/gen-news-highlights/novartis-and-ariad-separately-report-positive-alk-inhibitor-results/81253504

Posted in Anaplastic Large-Cell Lymphomas, Brain metastases, brigatinib-Alunbrig from Takeda, ceritinib - Zykadia from Novartis, Lung cancer, Potential Treatments, Research | Leave a comment

Abstract 9007 on Brigatinib update

The initial write up of the abstract 9007 was posted on May 19.

This update covers about 3 more months of data and brain mets.

Arm A (90 mg) median Progression Free Survival (PFS) increased from 8.8 months to 9.2 months. For arm B (180 mg) the median PFS increased from 11.1 months to 12.9 months. Probability of overall survival at 1 year was 71% for arm A and 80% for arm B.

For patients with measurable brain mets at baseline, for arm A the Objective Response Rate was 36% and for arm B the ORR was 67%. Median intracranial PFS was 15.6 months for arm A and not yet reached for arm B.

There is a press release on this topic on Ariad’s website.

Posted in Brain metastases, brigatinib-Alunbrig from Takeda, Lung cancer, Potential Treatments, Research | Leave a comment

Outcomes for ALK+ patients

Abstract e20550 is from Spain and involves 49 patients. Patients took 6 different ALK inhibitors. The abstract concluded “ALK+ patients who received targeted agents have prolonged survival despite brain metastases…. ALK inhibitors improve intracranial response rate and survival.”

Posted in alectinib - Alecensa from Chugai - Roche - GenenTech, Brain metastases, brigatinib-Alunbrig from Takeda, ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, lorlatinib - Lorbrena by Pfizer, Lung cancer, Potential Treatments, Research | Leave a comment

Discontinuing Crizotinib treatment

Abstract e20610 is from Canada and covers 97 patients. Post Crizotinib treatment 43% received Ceritinib, 20% received chemo and 37% received no additional treatment. Median overall survival was:

0.9 months for those who received no additional treatment,

7.6 months for those who received chemo, and

20.4 months for those received Ceritinib.

Posted in ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, Lung cancer, Potential Treatments, Research, Resistance to treatment | Leave a comment