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Eight Milestones Of 2016 In The War On Cancer

This article is more than 7 years old.

Only 22 novel drugs were approved by the U.S. Food & Drug Administration in 2016—way down from the 45 approved in 2015—and just six of the new entries are for treating or diagnosing cancer. Still, 2016 was far from a washout for oncology research. Here were some of the high points of the year in the war on cancer:

January 12: V.P. Biden is tapped to lead the new Cancer Moonshot. During the State of the Union address, President Barack Obama launched the Cancer Moonshot and appointed Vice President Joe Biden to lead the initiative. The goal is not just to speed new therapies to market, but also to improve access to treatment and come up with methods for detecting the disease early, when it’s easier to treat and cure. Biden spent much of the year tapping academics, drug company executives, patients and physicians for advice, as well as establishing five strategic goals for the Moonshot.

In October, the veep announced a new project called the Blood Profiling Atlas, which will try to accelerate the development of “liquid biopsies,” tests designed to detect early-stage cancer by tracking tiny bits of tumor DNA cast off into the bloodstream. Much to the surprise of some executives, he assembled an impressive list of organizations that might normally balk at the idea of working together to help build the atlas, including Novartis , Pfizer , Thermo Fisher and Foundation Medicine.

April 13: Napster billionaire Sean Parker launches a cancer institute. The glitzy star-studded gala that ushered in Sean Parker’s new cancer research institute may have drawn some ire, but the money the Napster founder and former Facebook president is devoting to the effort is nothing to sneeze at. The Parker Institute for Cancer Immunotherapy is backed by a $250 million grant to develop new therapies that deploy the body’s immune system to combat tumors. Furthermore, Parker persuaded six leading cancer institutes to participate—and to pool all the patents that come out of the effort, in the hopes that he can prevent intellectual property concerns from holding up breakthroughs. Participants include Memorial Sloan Kettering Cancer Center in New York, the University of Pennsylvania and the University of Texas MD Anderson Cancer Center.

April 28: AbbVie picks up Stemcentryx for $10B, setting high expectations for its lung cancer drug. AbbVie made a big bet on Stemcentryx, declaring when it acquired the company that it’s experimental drug, rovalpituzumab tesirine (Rova-T) would be a “multi-billion dollar peak revenue opportunity.” Rova-T is being tested in small cell lung cancer and works in a novel way—by targeting a protein called DLL3, which coats some cancer cells. AbbVie bought Stemcentryx, which was partly backed by Facebook billionaire Peter Thiel, for $5.8 billion plus $4 billion more in potential milestone payments.

A few months later, at the 2016 American Society of Clinical Oncology (ASCO) meeting, AbbVie presented data from a small trial showing that 39% of patients whose tumors expressed high levels of DLL3 responded to the drug. That said, it only extended median survival rates by one month. A larger trial, this time only with patients who have high levels of DLL3, is ongoing.

June 4: BMS’s immuno-oncology combination shines in a lung cancer trial. Drugs that inhibit “checkpoints” like PD-1, thereby allowing the immune system to recognize and attack cancer, have been all the rage over the last few years. But oncology researchers have long believed that combinations of immunotherapies would work better than any such treatment given alone. Bristol-Myers Squibb scored a big win in 2015, when a combination of its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab), which inhibits CTLA-4, was approved to treat some melanoma patients.

Then, at ASCO 2016, BMS wowed the oncology community again when it released data from a trial of the combo in advanced non-small cell lung cancer. In that trial, the overall response rate for patients whose tumors expressed the related checkpoint PD-L1 were 57%, vs. 28% for those who took Opdivo alone. The combination continues to be studied in a phase 3 trial.

June 29: PARP inhibitors make strides in ovarian cancer. Inhibiting a protein called PARP disrupts the process by which cancer cells repair their DNA, and several companies have been working on drugs that target this marker. AstraZeneca ’s PARP-inhibiting Lynparza (olaparib) was approved in 2014 to treat some women with ovarian cancer, but this year, upstarts Tesaro and Clovis showed they could be on track to steal significant market share with their PARP inhibitors.

Tesaro’s stock rose 85% to $68.78 in pre-market trading on June 29, after the company released trial results for its PARP inhibitor, niraparib, showing that the risk of progression dropped 73% in ovarian cancer patients with the gene mutation BRCA, 62% in those with another abnormality called HRD-positive, and 55% in people who were BRCA-negative. The FDA tagged the drug for priority review on December 20, putting Tesaro’s shares on track to finish the year north of $135 a share. The announcement came a day after the FDA approved Clovis’s PARP inhibitor, Rubraca (rucaparib), for BRCA-positive patients. That approval came two months earlier than expected, pushing Clovis’s stock up 9% to $40.48.

August 22: Pfizer doubles down on oncology with a $14B bet on Medivation Speaking of PARP inhibitors, another sign of how hot they are came when Pfizer laid out $14 billion to acquire Medivation, which is developing another drug in the class, talozaparib, to treat BRCA-positive breast cancer. That drug is in late-stage trials, so it’s not yet clear just how much value it will hold for Pfizer. What’s more clear is Xtandi (enzalutamide), Medivation’s drug that works in some men with prostate cancer by lowering testosterone. It brought in more than $2 billion in sales in the year ending in August, setting off a reported bidding war for Medivation. By winning the deal, Pfizer will double its oncology sales to $5 billion a year.

December 4: Kite Pharma pulls ahead in the CAR-T race with first FDA submission. The effort to develop specially engineered cancer-killing cells known as chimeric antigen T-cells (CAR-T) had plenty of ups and downs during the year. But in the race to get the cells approved to treat some types of blood cancer, Kite Pharma clearly pulled ahead of its rivals, Novartis and Juno. Kite had been promising to file to the FDA for approval by the end of the year, and it has now started that process, initiating a rolling submission for approval of KTE-C19 to treat patients with relapsed B-cell non-Hodgkin lymphoma. The company says it will be ready to market the product in 2017 if it’s approved.

Novartis, which has been collaborating with the University of Pennsylvania, says it’s on track to file for approval of CTL019 in early 2017, though it did spook investors in August by shutting down the business unit it had created to pursue CAR-T treatments. On the same day Kite initiated its FDA submission, Novartis announced that in an interim analysis of a study of its CART in pediatric acute lymphoblastic leukemia, 82% of patients achieved remissions.

The loser in this race? That would be Juno Therapeutics, which revealed in July that three patients died in a phase 2 trial of its CAR-T, JCAR015. The trial quickly resumed after the company determined that the problem was coming from the chemotherapy drug fludarabine, which was being used to pre-condition patients to receive the engineered T-cells. But Juno put the trial on hold again in November after two additional patient deaths, and it has yet to say what the future holds for that product.

December 13: 21st Century Cures Act becomes law, promising up to $4.8 billion for precision oncology research. President Obama signed the 21st Century Cures Act, which establishes $4.8 billion in federal funding for the Cancer Moonshot and the Precision Medicine Initiative. Both programs prioritize “precision medicine,” the term used to describe research that seeks to match patients with the right therapies based on their unique genetic mutations and other factors that can be targeted with drugs. The funding could fuel an already-established proliferation of precision oncology trials being led by several companies and organizations such as the Leukemia & Lymphoma Society.

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