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Roche's HER2 Breast Cancer Segment Tops List of PGx Drug Sales in Q2

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Originally published Aug. 13.

The combined sales from Roche's treatments for HER2-positive breast cancer took the lead for pharmacogenomically targeted cancer drugs during the second quarter.

For the three months ended June 30, Roche reported that its products for treating women with HER2-overexpressing breast cancer brought in 3.3 billion Swiss Francs ($2.68 billion), an 11 percent increase from the second quarter a year ago. Although sales of Roche's original HER2 targeted breast cancer drug Herceptin (trastuzumab) were flat at 1.5 billion Swiss Francs from the year-ago quarter, the growth in the HER2 breast cancer segment was driven by the addition of two recently approved drugs, Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).

Perjeta, in combination with Herceptin and docetaxel, is a treatment for HER2-positive breast cancer patients with metastatic or locally recurrent, unresectable disease, who haven't received anti-HER2 treatments or chemotherapy for their advanced stage cancer. Kadcyla was approved by the FDA in February as a treatment for HER2-positive metastatic breast cancer patients who have received prior treatment with Herceptin and taxane chemotherapy. The antibody-drug conjugate combines Herceptin with the chemotherapy DM1 via a stable linker.

Perjeta is intended as a first-line HER2-positive, metastatic breast cancer treatment, while Kadcyla is indicated for later stages of treatment. Perjeta brought in 108 million Swiss Francs in global sales during the second quarter, more than double what it garnered in sales in the first quarter of this year. Meanwhile, Kadcyla's global sales for the second quarter soared to 83 million Swiss Francs, from 18 million Swiss Francs in the first quarter. The majority of the sales during the quarter for Perjeta (88 million Swiss Francs) and Kadcyla (82 million Swiss Francs) came from the US market.

Between 15 percent and 20 percent of all breast cancers tumors overexpress the HER2 protein. With the patent for Herceptin slated to expire next year in Europe and approximately four years later in the US, Roche and subsidiary Genentech will likely continue to push for strong market penetration of Kadcyla and Perjeta in the coming years in order to maintain profits from its HER2 breast cancer franchise.

"There is still good demand in the US for Herceptin," Daniel O'Day, CEO of Roche Molecular Diagnostics, said during a recent call with investors to discuss Roche's second quarter earnings. "Having said that, of course, with the launch of Perjeta and with Kadcyla, we would expect some erosion … of Herceptin over time as those two products come into play."

Leukemia

Novartis' leukemia treatment franchise, including Gleevec (imatinib) and Tasigna (nilotinib), garnered sales of $1.5 billion, a 7 percent bump from the previous year's Q2. Both of these drugs treat Philadelphia-chromosome positive chronic myeloid leukemia, which is characterized by the Bcr-Abl fusion gene. Sales of Gleevec during the quarter were $1.2 billion, representing 1 percent growth, while Tasigna sales jumped 38 percent year over year to $315 million.

Gleevec is approved also as a treatment for metastatic or unresectable KIT-positive gastrointenstinal tumors and Ph-positive lymphoblastic leukemia. Approximately 95 percent of CML patients and up to 30 percent of acute lymphoblastic leukemia patients have the Bcr-Abl translocation.

Gleevec is currently facing generic competition in a number of countries, including Brazil, Russia, Canada, Turkey, and Mexico. In the US, Gleevec's active ingredient is slated to lose patent protection in 2015. As a result, Novartis is looking to drive adoption of Tasigna in Ph-positive CML. The company said that during the second quarter sales of its Bcr-Abl franchise was driven by Tasigna.

Bristol-Myers Squibb's Ph-positive CML drug Sprycel (dasatinib) netted $312 million in global second quarter net sales, a 28 percent increase from the previous year's second quarter. In the US, net sales for Sprycel grew 48 percent year over year to $135 million.

The FDA last December approved Ariad Pharmaceuticals' Iclusig (ponatinib) as a treatment for patients with chronic, accelerated phase, or blast phase chronic myeloid leukemia or Ph-positive acute lymphoblastic leukemia who are resistant or intolerant to tyrosine kinase inhibitors. The drug targets the Philadelphia chromosome gene mutation T315I, which is found in most CML patients and confers resistance to marketed TKIs. Net sales for Iclusig in the second quarter were $13.9 million.

Although it has been approximately half a year since the approval of Pfizer's molecularly targeted leukemia drug Bosulif (bosutinib), the company hasn't yet broken out revenues of the drug on a quarterly basis. The FDA approved Bosulif late last year for patients with chronic phase, accelerated phase, and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia who have received treatment with one or more tyrosine kinase inhibitors and who are non-responsive to Gleevec (imatinib), Tasigna (nilotinib), and Sprycel (dasatinib).

Lung Cancer

Meanwhile, the US Food and Drug Administration in May approved a new indication for Roche's Tarceva (erlotinib), as a first-line treatment for metastatic non-small cell lung cancer patients with EGFR mutated tumors. Worldwide sales for Tarceva during the quarter were 355 million Swiss Francs, a nine percent increase from the second quarter of last year. In the US, the drug's sales were 169 million Swiss Francs, an 18 percent jump from the previous year's second quarter.

O'Day said during the investor call that "Tarceva [was] making progress … with a 4 percent growth, good uptake in first line," and noted that the company is "seeing stabilization in the second-line" setting as well. EGFR mutations occur in 10 percent to 15 percent of the approximately 200,000 people diagnosed with advanced NSCLC each year in the US.

In Europe, Tarceva competes with AstraZeneca's Iressa (gefitinib) in the EGFR-mutated NSCLC space. Iressa brought in $156 million in revenues in the second quarter, a 7 percent jump from the previous year. AstraZeneca doesn't market Iressa in the US.

In July, the FDA also approved Boehringer Ingelheim's Gilotrif (afatinib) as a first-line treatment for metastatic NSCLC patients whose tumors harbor EGFR exon 19 deletions or exon 21 L858R substitutions. The coming months will show whether the sales of Roche's Tarceva and Iressa will be markedly impacted by the introduction of Gilotrif.

During the second quarter, Pfizer also pushed into the pharmacogenomically targeted NSCLC market with Xalkori (crizotinib). Between 3 percent and 5 percent of NSCLC patients have tumors with ALK rearrangements. Pfizer has partnered with Abbott to provide a companion test that gauges ALK mutations and picks out which patients will respond to the drug.

Xalkori had $67 million in revenues in the last quarter, representing 191 percent growth over the second quarter of 2012. US drug revenues were $35 million, a 94 percent increase from the year-ago period. According to Pfizer CEO Ian Read, revenues from Xalkori, alongside other newly launched drugs, helped grow the company's "innovative business" segment by 28 percent during the quarter.

Melanoma

Roche/Genentech's BRAF inhibitor, Zelboraf (vemurafenib), for melanoma, has been on the market now for two years. The treatment brought in 87 million in Swiss Francs, a 46 percent increase from the year-ago second quarter. In the US, Zelboraf sales were 35 million Swiss Francs, compared to 30 million Swiss Francs in the second quarter last year. Approximately 50 percent of melanoma tumors harbor mutations in the BRAF gene.

During the second quarter, the FDA approved two new personalized treatment options from GlaxoSmithKline for patients with metastatic or unresectable melanoma whose tumors harbor mutations in the BRAF gene: Tafinlar (dabrafenib) and Mekinist (trametinib). The BRAF inhibitor Tafinlar treats melanoma patients whose tumors have BRAF V600E mutations. Mekinist, a MEK inhibitor, is indicated to treat patients who express the BRAF V600E or V600K mutations.

Both of these drugs were approved with a companion test, the THxID BRAF Kit developed by BioMérieux, which gauges both V600E and V600K mutations. However, GSK hasn't yet begun reporting earnings from these treatments.

Colorectal Cancer

Amgen and Bristol-Myers Squibb both market metastatic colorectal cancer drugs for patients without KRAS-mutation positive tumors, Vectibix (panitumumab) and Erbitux (cetuximab), respectively. Between 30 percent and 50 percent of colorectal cancers harbor KRAS mutations, and therefore, cannot receive these drugs.

During the second quarter, Bristol-Myers Squibb saw a 4 percent dip in global Erbitux sales to $171 million from $179 million in the comparable quarter of last year. In the US, Erbitux sales were $168 million, a 5 percent decline from $176 million in Q2 2012.

Amgen's Vectibix, meanwhile, gained 3 percent in global sales during the quarter, from $90 million last year to $93 million this year. US sales of Vectibix during the quarter accounted for around $31 million, while more than 50 percent of Vectibix sales were from the European market.

During a call with investors recently, Amgen officials noted that the company has formed a joint venture in China with Zhejiang Beta Pharma to commercialize Vectibix in that country by 2015. Additionally, the company is trying to expand the indication for Vectibix for later-stage colorectal cancer patients, which should add to product sales in the coming years.

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