The big oncology event in Europe, ESMO, will be held in two weeks between October 19th and October 23, 2018 in Munich, Germany. Below is a list of stocks to watch leading up to and during the conference. I exclude Phase 1 data releases because the failure rate is too high for good risk versus reward setups IMO.
Abstracts will be published online via the ESMO website at 00:05 CEST on Tuesday, October 9, 2018.
AZN and MRK Stocks
Astrazeneca (AZN) and Merk (MRK) and their Lynparza, SOLO 1, for first-line ovarian cancer. The Phase 3 PFS endpoint was met on June 27, 2018. Presentation at ESMO, October 21, 2018.
Lynparza significantly delays disease progression in Phase III 1st-line SOLO-1 trial for ovarian cancer. Lynparza met primary endpoint of progression-free survival in women with BRCA-mutated advanced ovarian cancer and showed a safety profile consistent with previous trials. AstraZeneca and MSD’s Lynparza is the only PARP inhibitor to demonstrate significant activity in the 1st-line maintenance setting.
Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with Lynparza maintenance therapy had a statistically-significant and clinically-meaningful improvement in progression-free survival compared to placebo. The safety and tolerability profile of Lynparza was consistent with previous trials. Based upon these data, AstraZeneca and MSD plan to initiate discussions with health authorities regarding regulatory submissions.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the 1st-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Building on the strong data we’ve seen with Lynparza to date, the data from SOLO-1 reinforces Lynparza’s ability to provide meaningful disease control with a well-characterised safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the 1st-line maintenance setting as quickly as possible.”
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2012, there were nearly 239,000 new cases diagnosed and around 152,000 deaths. For newly diagnosed advanced ovarian cancer, the primary aim of treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life with the intent of achieving complete remission or cure.
BioLineRx (BLRX) with BL-8040 in combination with KEYTRUDA, COMBAT trial for pancreatic cancer. The Phase 2 study was initiated back in September 2016. Top-line data is due at ESMO.
Philip A. Serlin, Chief Executive Officer of BioLineRx, said, “…data from our ongoing COMBAT Phase 2a immuno-oncology trial support continued development in pancreatic cancer, as we expand our collaboration with Merck, with the addition to the existing study of a new cohort with 30-50 patients investigating the triple combination of BL-8040, KEYTRUDA and chemotherapy. The new cohort will focus on second-line pancreatic cancer patients and we are hopeful for significant synergies from the triple drug combination in this very difficult-to-treat population.”
Clovis Oncology (CLVS) TRITON2 with Lucitanib, HR+ Her2, for metastatic breast cancer. Phase 2 data presentation at ESMO, October 21, 2018.
“We were very pleased to receive the expanded maintenance treatment indication for Rubraca in the U.S. in early April, and while it is early days in the launch, we are receiving very positive feedback to the broader and earlier-line label from clinicians,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are well positioned now with a strong balance sheet and a robust clinical development program for Rubraca, initiating new Clovis-sponsored single-arm studies in ovarian and bladder cancers with Opdivo by year-end, and looking forward to presenting initial data from TRITON2 in prostate cancer at ESMO in October.
The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm study enrolling patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of androgen-receptor (AR) targeted therapy. The Company plans to present initial data from the ongoing TRITON2 study at ESMO in October 2018.
Merck (MK) has another ESMO data release beyond the Lynparza, SOLO 1 trial mentioned above. This data release is for Keytruda KN-048 for head and neck cancer. Phase 3 trial met OS primary endpoint on July 25, 2018 but PFS endpoint not yet reached. Merk will present its data at ESMO on October 22, 2018.
Merck’s anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed PD-L1 (Combined Positive Score (CPS) ≥20). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with KEYTRUDA monotherapy in these patients resulted in significantly longer OS compared to cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin) plus 5-Fluorouracil (5-FU), the current standard of care for HNSCC in the first-line treatment setting. At the time of the interim analysis, the dual-primary endpoint of progression-free-survival (PFS) for patients whose tumors expressed PD-L1 (CPS≥20) had not been reached.
“This interim analysis of KEYNOTE-048 trial has shown that KEYTRUDA monotherapy has the potential to help patients with head and neck cancer whose tumors express high-levels of PD-L1,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to presenting these initial results from the KEYNOTE-048 trial at an upcoming medical meeting, and are grateful to the investigators and patients for their continued involvement in this important study.”
KEYNOTE-048 is a Phase 3, randomized, open-label trial (ClinicalTrials.gov, NCT02358031) designed to investigate KEYTRUDA in the first-line setting as monotherapy or in combination with a platinum chemotherapy (cisplatin or carboplatin) plus 5-Fluorouracil (5-FU), compared to cetuximab with platinum chemotherapy (cisplatin or carboplatin) plus 5-FU. The dual primary endpoints were overall survival (OS) and progression-free survival (PFS)The secondary endpoints of the study were PFS (at 6 months and 12 months), Objective Response Rate (ORR), and Time to Deterioration in Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire.
Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. The leading modifiable risk factors for head and neck cancer include tobacco and heavy alcohol use. Other risk factors include infection with certain types of HPV, also called human papillomaviruses. Worldwide, there were approximately 686,000 new cases of head and neck cancer in 2012, and around 376,000 died from this disease. In the U.S., there were an estimated 63,000 new cases diagnosed in 2017.
Mirati Therapeutics (MRTX) Sitravatinib plus nivolumab for non-small cell lung cancer (NSCLC). A Phase 2 update is due at ESMO on October 22, 2018.
Sitravatinib (MGCD516) is being evaluated in selected patients with specific genetic alterations that are drivers of tumor growth, with an initial focus on NSCLC and in other solid tumors where sitravatinib may confer a benefit. Sitravatinib is a tyrosine kinase inhibitor with demonstrated potent inhibition of a closely related spectrum of tyrosine kinases, including RET, CBL, CHR4q12, DDR and Trk, which are key regulators of signaling pathways that lead to cell growth, survival and tumor progression. Mirati owns the worldwide rights to Sitravatinib (MGCD516).
Roche Holding Ltd ADR (RHHBY) with Tecentriq plus nab-paclitaxe, IMpassion 130 for first-line triple negative breast cancer (TNBC). Phase 3 data released July 1, 2018. PFS endpoint met. Data to be presented ESMO on October 20, 2018.
Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer. First Phase 3 immunotherapy study to demonstrate a statistically significant improvement in progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1 positive first-line metastatic triple negative breast cancer (TNBC) populations.
Roche announced back on July 2, 2018, that the Phase 3 IMpassion130 study met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to treat and PD-L1 positive population with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival (OS) is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis.
“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”
Breast cancer is the most common cancer among women with more than 1.67 million diagnosed worldwide each year. Triple negative breast cancer represents 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification. Patients with metastatic triple negative breast cancer generally experience rapid progression and shorter overall survival compared to other subtypes of breast cancer.