In a key tri­umph for Roche’s run­ner-up check­point Tecen­triq, the FDA sanc­tioned a com­bo of the PD-L1 with Cel­gene’s Abrax­ane for front­line use in triple neg­a­tive breast can­cer.

The ac­cel­er­at­ed ap­proval marks the first can­cer im­munother­a­py reg­i­men ap­proved for this type of metasta­t­ic can­cer, the phar­ma gi­ant said, just months af­ter re­port­ing some his­toric Phase III da­ta on pro­gres­sion-free sur­vival.

San­dra Horn­ing speaks at an End­points @ #JPM19 End­points News

Click on the im­age to see the full-sized ver­sion

In the IM­pas­sion130 study, Tecen­triq plus Abrax­ane (the chemother­a­py nab-pa­cli­tax­el) “sig­nif­i­cant­ly re­duced the risk of dis­ease wors­en­ing or death (PFS) by 40% com­pared with nab-pa­cli­tax­el alone,” with a me­di­an PFS of 7.4 months ver­sus 4.8 months. The haz­ard ra­tio came in at 0.60 and p<0.0001.

Tecen­triq is now sanc­tioned to treat pa­tients whose tu­mors ex­press PD-L1 — some­thing that needs to be ver­i­fied by a com­pan­ion di­ag­nos­tic from Roche. Ap­proved con­cur­rent­ly for this in­di­ca­tion, the VEN­TANA PD-L1 (SP142) As­say scans tu­mor-in­fil­trat­ing im­mune cells for PD-L1.

Tar­get­ed ther­a­py has long elud­ed pa­tients suf­fer­ing from triple neg­a­tive breast can­cer, as the com­mon types of re­cep­tors — es­tro­gen re­cep­tor, prog­es­terone re­cep­tor and HER2/neu – are not ex­pressed on their tu­mors. The ap­proval of Tecen­triq rep­re­sents “a mean­ing­ful step for­ward in the un­der­stand­ing of this dis­ease,” said Roche head of glob­al de­vel­op­ment San­dra Horn­ing.

Trail­ing be­hind Mer­ck and Bris­tol-My­ers Squibb, the phar­ma gi­ant will need to get out well ahead of the com­pe­ti­tion in key can­cer ar­eas if they ex­pect to hold on to their third-ranked po­si­tion in the mar­ket, as As­traZeneca moves ahead with its ad­van­tage in one im­por­tant niche of non-small cell lung can­cer.

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?