Oncoral (irinotecan oral) / Ascelia - LARVOL DELTA

Third US patent strengthens patent protection for Ascelia Pharma's Oncoral (daily tablet irinotecan) (Market Screener) - "Ascelia Pharma AB...announced today the decision of the US Patent and Trademark Office (USPTO) to allow the issuance of a third patent covering the composition of Oncoral. Ascelia Pharma has received a positive Notice of Allowance from the United States Patent and Trademark Office (USPTO) for United States patent application no. 17/865,734 for Oncoral....The new patent covers the tablet composition and will provide protection until 2035 plus potential extension in the US."

Patent • Oncology

Expert Point of View: Laura Goff, MD, MSCI (THE ASCO POST) - "Invited discussant Laura Goff, MD, MSCI...said that with the results of NAPOLI-3, clinicians have a third effective first-line regimen for metastatic pancreatic cancer."

Media quote

Anti-EGFR/Chemo Combos Allow for Tailored Approach in mCRC (OncLive) - "EGFR inhibitors play a prominent role in the treatment of patients with metastatic colorectal cancer (mCRC), but their impact is more pronounced with the addition of triplet chemotherapy, explained Ardaman Shergill, MD. She added that the availability of oxaliplatin and irinotecan allowed for tailored approaches based on underlying neuropathy and liver dysfunction."

Media quote

"Analyguiden: Viktigt avtal för Oncoral https://t.co/UgOAEho3Bw" (@CisionNews)

ONCORAL-Covid: Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients (clinicaltrials.gov) - P=N/A; N=170; Recruiting; Sponsor: Hospices Civils de Lyon

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease • Oncology • Oral Cancer

TheraSphere Y-90 Plus Chemo Prolongs PFS, hPFS in Second-Line Metastatic CRC (OncLive) - P3, N=428; "The addition of TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres to standard-of-care second-line chemotherapy in patients with colorectal cancer liver metastases led to a significant improvement in progression-free survival (PFS) and hepatic PFS (hPFS) over chemotherapy alone, meeting both primary end points of the ongoing EPOCH trial....'EPOCH is the first positive phase 3 global study of Y-90 transarterial radioembolization [TARE] and chemotherapy in the second-line treatment of patients with colorectal liver metastases,' Mary F. Mulcahy, MD...said in a presentation on the data. 'This is the first arterial radiotherapy device to demonstrate a statistically significant delay in progression in metastatic CRC.'"

Media quote • P3 data

Thromboembolic events and thromboprophylaxis associated with immunomodulators in multiple myeloma patients: a real-life study. (PubMed, J Cancer Res Clin Oncol) - "Thromboprophylaxis was systematically performed in myeloma patients treated with immunomodulatory drugs in this real-life retrospective cohort. However, the choice of anticoagulant or anti-platelet agent remains debatable, as adherence to existing guidelines was variable."

Clinical • Journal • Cardiovascular • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology • Oral Cancer • Thrombosis • Venous Thromboembolism

Chemotherapy-Free Options Remain Unmet Need in Colorectal Cancer (Targeted Oncology) - "Zev A. Wainberg...explained the importance of having a chemotherapy-free option available for patients with colorectal cancer. Currently, 2 chemotherapy regimens are widely used as treatment of patients with colorectal cancer, including the FOLFIR regimen (irinotecan, fluorouracil (5-FU), and folinic acid [leucovorin]) and the FOLFIRNOX regimen (Folinic acid, fluorouracil, irinotecan, and oxaliplatin). Wainberg says that many oncologists are now hoping for individualized options."

Video

"Ascelia Pharma presents clinical development plan for Oncoral as a novel chemotherapy https://t.co/BbMQIhZMfx" (@CisionNews)

Clinical • Oncology

Treating colorectal cancer in the time of COVID-19 (THE ASCO POST) - "First, as Dr. Grothey noted, a diagnosis of any kind of cancer places patients at risk for illness....'My main concern is trying to ensure that the intensity of therapy is appropriate for the patient, given the potential risks associated with treatment,' Dr. Kopetz said....Dr. Bendell said she becomes concerned even before she prescribes treatment....The panelists agreed on several approaches for mitigating this risk (with further elaboration below): In appropriate patients, shift away from intensive regimens to less intense therapy (ie, give a doublet, not a triplet)....Consider giving treatment breaks."

Media quote

The expanding continuum of care in metastatic colorectal cancer (Targeted Oncology) - "'The unmet needs that patients have in the metastatic setting is duration of time and quality of life [QOL],' noted Grothey in an Investigator Perspectives video interview with Targeted Therapies in Oncology....This article, featuring additional insights from Grothey, reviews the evolving treatment landscape and continuum of care for mCRC, with an emphasis on the role of newer agents in the third- and fourth-line settings-particularly the targeted agent regorafenib and the chemotherapy agent TAS-102....According to Grothey, frontline choices are more granular than they have ever been."

Interview

Encounters between medical and lay knowledge in therapeutic patient education. A qualitative study based on an oral chemotherapy program. (PubMed, Patient Educ Couns) - "Dedicated TPE program objectives for patients undergoing oral chemotherapy should recognize not only the value of medical knowledge but also of lay knowledge."

Clinical • Journal • Oncology

Management of R/R mCRC: Sequencing for later-line therapies (OncLive) - "Marwan Fakih, MD...When do I consider TAS-102? I consider it in my patients who have progressed on those agents. I consider it in patients who have normal liver function, because we also know that patients who have high bilirubin have higher toxicity with TAS-102...Scott Kopetz, MD...But in my practice, depending on the patients' adverse effects, tolerance, and performance status, I'll commonly utilize regorafenib followed by TAS-102 and then an EGFR rechallenge as well. Axel Grothey, MD...The investigators did a lot of analysis, including the use of ctDNA to detect mutant clones, and 1 of the hypotheses is that when we use EGF receptor antibody later and regorafenib first, we delay the onset, delay the emergence of mutated RAS and BRAF-mutated clones, which could then also drive biology because they're poor prognostic factors. But that's just a hypothesis. We need to look at more markers or rerun the study, get more data."

Video

Ascelia Pharma publ : Patent for oncoral approved in Japan (Market Screener) - “Ascelia Pharma AB…announced that the patent application for Oncoral has been approved in Japan. The approval in Japan adds to the already obtained patents in the US and a selected number of countries in Europe and China. The patent secures the intellectual property protection rights for Oncoral until year 2035 plus potential patent extension. ‘We are very pleased to also have the patent for Oncoral approved in Japan as the unmet medical needs for gastric cancer treatment in Japan are significant.”

Patent • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

mCRC: Second-line treatment decisions (Targeted Oncology) - "Axel Grothey, MD...So second-line choices clearly depend on first-line treatments, and of course, on biologic parameters, molecular parameters, like for instance, BRAF mutation testing....It really depends on toxicity and progression of disease. These are triggers for switching to a different regimen....In my clinical practice, I have not yet embraced the study's sequence. I use EGFR antibodies in RAS wild-type, BRAF wild-type left-sided tumors before I use regorafenib."

Video

R/R metastatic CRC: Correct, IMblaze370, and ReDOS trials (OncLive) - "Insights From: Marwan Fakih, MD...Axel Grothey, MD...Scott Kopetz, MD, PhD...Axel Grothey, MD: The data that we have for efficacy of treatment in third-line therapy are based on large randomized trials that showed survival benefit for drugs like regorafenib and TAS-102 [trifluridine, tipiracil]....Regorafenib came out as the de facto winner of this study, not in terms of statistically significant prolonged overall survival. But survival was, again, better than expected in the range of about 8.5 months, 8.6 months in overall survival. It clearly established itself again as a standard of care in this setting."

Video

MCRC: Sequencing based on RAS status and tumor sidedness (OncLive) - "Richard Kim, MD....So, if you take all that into consideration, it seems like there is maybe some modest activity of EGFR inhibitors in right-sided tumors....Scott Kopetz, MD, PhD....I would discourage the continuation of anti-EGFR therapy in the second line if they received it in the first line, for example. And we really think that the more time between the exposures of anti-EGFR therapy, the better."

Clinical • Video

Dr. Kopetz on the rationale and design of the BEACON CRC study in mCRC (OncLive) - P3, N=665; BEACON CRC (NCT02928224); Sponsor: Array BioPharma; "Scott Kopetz, MD, PhD, FACP...discusses the rationale and primary endpoints of the BEACON CRC study in BRAF V600E-mutant metastatic colorectal cancer (mCRC)....The primary study met both of its endpoints of higher objective response rate (ORR) and overall survival (OS)."

P3 data • Video

Custom combinations maintain quality of life of patients with colorectal or liver cancer [Google translation] (Yahoo News) - "At the San Francisco 2020 Gastrointestinal Cancer Symposium, Dr. Scott Kopetz...presented the quality of life data of the BEACON study patients, which was a secondary outcome."

ASCO GI 2020: Abstract recommendations in colorectal cancer from Dr. Axel Grothey (PracticeUpdate) - "Dr. Axel Grothey...recommends the following abstracts in colorectal cancer being presented at the ASCO Gastrointestinal Cancers Symposium...Pembrolizumab for advanced anal squamous cell carcinoma (ASCC): Results from the multicohort, phase II KEYNOTE-158 study....Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)."

Online posting